Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were published in the New England Journal of Medicine, one of the world's most prestigious peer-reviewed medical journals. For the details of the paper, please refer to: www.nejm.org/doi/full/10.1056/NEJMoa2212948.The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai's human health care mission. Eisai and Biogen remain committed to disclosing data and information on lecanemab. If approved, we will work to bring the drug expeditiously to people living with early AD and their families.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2022/pdf/enews202284pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Younger Colorectal Cancer Population Highlights the Importance of Early Screening, Highly Sensitive Test Product Prenetics has Launched the Market

HONG KONG, Sep 2, 2022 - (ACN Newswire via SEAPRWire.com) - Colorectal cancer (CRC) has become one of the main cancers threatening the health of human beings. In the United States and China, CRC has ranked among the top three cancers that leads to death.CRC screening has been proven to be one of the most effective tools for preventing colorectal cancer. Research indicated that since screening was first recommended in 1980 in the United States, the incidence rate of CRC has dropped by 40%. Meanwhile, it's also important to follow the updated evidence, ensuring that the screening is suitable for the people who benefit most.The onset of Disease Tends to be YoungerLatest research has indicated that 94% of newly CRC cases occur in adults over 45 years old. Among which, the number of newly onset and death cases occurring in individuals under the age of 50 has increased a lot. CRC diagnosis among younger adults is growing.Therefore, National Comprehensive Cancer Network (NCCN) has updated its guidance in 2021, suggesting that people at average risk shall conduct screening from the age of 45.U.S. Preventive Services Task Force (USPSTF) also pointed out that all asymptomatic adults aged 45 years old or above are exposed to CRC risks. Even without high-risk factors, they're recommended to take CRC screening.Although the incidence rate of CRC is as high as thyroid cancer and breast cancer, chance of treating CRC is better at an early age. It is very important to early find and treat the disease to ensure a higher survival rate. Research by the world-leading diagnosis and genetic health testing company Prenetics (PRE.O) showed that the 5-year survival rate of stage I and II CRC is up to 90% and stage III is 72.8%. It falls to 15.1% for stage IV CRC.Despite the significantly higher survival rate in the early treatment of CRC, unfortunately nearly half of the CRC cases are detected in the advanced stage, leading to extremely difficult treatment. Lacking a convenient and highly effective detection method is the vital cause of this phenomenon.Significant Reform of CRC DetectionCRC screening has always relied on invasive detection methods including colonoscopy. Since such detection may cause pain or discomfort, some patients refuse the screening.With the rising popularity of genetic detection science, CRC screening has welcomed a significant reform. Currently, a non-invasive and at-home screening test product - ColoClear has been introduced by Prenetics and New Horizon Health to the Southeast Asia market, which can detect pre-cancerous lesions and early, middle, and advanced stage CRC in an effective way.Combining advanced stool DNA technology with a fecal immunochemical test (FIT), ColoClear is easier, cheaper, and simpler and has high sensitivity, up to 96%, which is comparable to the traditional colonoscopy.On top of ColoClear, CircleDNA, a home health diagnosis product of Prenetics that give over 500 test reports in 20 categories, which plays an important role in the early detection of cancer and other potential disease risks. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

New Horizon Health Announced 2022 Interim Report: Revenue Up 414% YoY, Gross Margin Climbs to 82%

HANGZHOU, Aug 19, 2022 - (ACN Newswire via SEAPRWire.com) - New Horizon Health (6606.HK), China's leading biotechnology company for early cancer screening, announced its half-year results for the year ended June 30, 2022 today.Based on the financial information before the audit as of June 30, 2022, New Horizon Health achieved total revenue of RMB226 million in the first half of 2022, an increase of 414% over the same period in 2021; achieved a gross profit of RMB185 million, an increase of 650% over the same period in 2021; gross profit margin climbed to 82.0% from 56.2% in the first half of 2021. The Company's adjusted net loss for the half-year was RMB106 million and the adjusted net loss rate(1) narrowed significantly from 221% to 47%; the ratio of expenses to sales(1) dropped significantly from 161% to 86%, and the ratio of management expense to sales(1) dropped significantly from 80% to 23%. The Company's total cash, including time deposits, cash, and cash equivalents, amounted to RMB1.65 billion.The Company announced its cervical cancer screening product, CerviClear(TM), which had been launched in a large-scale prospective multi-center registered clinical trial in June 2022. CerviClear(TM) is the world's first HPV cervical cancer screening product that provides painless and non-invasive urine self-sampling at home, covering a comprehensive range of 14 high-risk HPV viruses. The clinical trial for LiverClear(TM) is progressing well and is expected to be launched in the fourth quarter of 2022 or the first quarter of 2023. As of June 30, 2022, the Company's R&D expenses(1) were RMB39.4 million, an increase of 111% over the same period in 2021."The results of the interim report were not easy to get. New Horizon Health's team is faithful to its promise that it is able to do what it says and do what it does. The Company's revenue in the first half of the year has exceeded last year's full-year revenue. The performance growth is mainly attributed to the increase in revenue and gross profit of ColoClear and Pupu Tube, as well as the listing of UU Tube. The underlying logic of the high growth and high gross profit of the three products is that more and more people with high risk are accelerating the change of concept, attaching importance to the risk prevention and control of high incidence cancer in personal and family health management, recognizing the important value of cancer early screening product compliance and willing to pay for it", the Chairman and CEO of New Horizon Health, YeQing ZHU, said, "Cancer early screening products are both serious medical and consumer products, and the huge market opportunity is backed by the high barrier of research and development and compliance as well as the high investment in market education. The necessary condition for the approval of cancer early screening products under New Horizon Health is solid prospective large-scale multi-center registration clinical validation, which is the strong barrier of our diversified business strategy and the foundation of user trust."Normalization of COVID-19 epidemic accelerates the market education process for early screening at home: ColoClear and Pupu Tube continue to see 3-digit revenue growthColoClear achieved revenue of RMB73.6 million in the first half of 2022, representing an increase of 419% over the same period in 2021. The shipment volume in the first half of the year was approximately 294,600 kits, representing an increase of 143% over the same period in 2021. The increase in revenue of ColoClear was mainly due to the increase in volume sold and recognized as revenue and the increase in average recognition unit price.China's first at-home self-testing FIT test product, Pupu Tube, achieved revenue of RMB68.5 million in the first half of 2022, an increase of 132% over the same period in 2021; and achieved shipment of 2,929,700 units, an increase of 54% over the same period in 2021. The increase in revenue recognized by Pupu Tube was mainly due to the increase in sales volume and the increase in the average unit price (including the increase in the unit price of direct-to-consumer pipeline and the increase in the unit price of health check centers).Other than New Horizon Health, no domestic player has yet announced the launch of a large-scale prospective multi-center registration clinical trial for colorectal cancer screening. ColoClear is the only product approved by the National Medical Products Administration of China for screening cancer. Pupu Tube is the only approved product for at-home self-testing of FIT in China. In February 2022, ColoClear's multi-target stool FIT-DNA technology was recommended by the latest version of the Cancer Foundation of China's "China Integrated Cancer Treatment Guidelines", making it the only molecular early screening technology in China to be included in all national guidelines for colorectal cancer prevention and treatment.In the first half of 2022, the policy of early screening of cancer at home was intensively favorable. The "14th Five-Year Medical Equipment Industry Development Plan ", the "14th Five-Year National Health Plan " and the "14th Five-Year Bio-economic Development Plan " all focus on "early screening and health management of key diseases" such as cancer and in vitro diagnosis in home scenes. The normalization of the detection of COVID-19 epidemic has accelerated the public's awareness of home screening and healthy "symptom-free" people.The only consumer self-test for H. pylori testing: $83.5 million in half-year sales revenue for UU TubeAs of June 30, 2022, the sales revenue of UU Tube since its listing on January 18, 2022, was RMB83.5 million.On December 31, 2021, UU Tube was approved for registration as a Class III medical device by the National Medical Products Administration of China and is the only product in China that is suitable for "consumer self-testing" for H. pylori detection, for which we have the exclusive patented design of the "pregnancy test stick" which is an integrated design for sampling and testing.Data show that more than half of the users of UU Tube are women, nearly 50% are aged 31-40, and people aged 24-30 and 40-50 are also the main users. Jiangsu, Guangdong and Zhejiang have ranked the top three provinces in terms of the number of UU Tube users, and household users are more concerned about the detection and prevention of H. pylori.The prevention and control of H. pylori is a major focus of the science of gastric cancer prevention and has been receiving widespread attention from the media and the public. Data show that in the first half of 2022, the epidemic prevention and control led to a significant decline in the measurement of H. pylori breath tests in hospitals and health checkups, while the number of online and offline gastroenterology consultations continued to rise during the same period, effectively boosting consumer demand for home testing of H. pylori and strongly supporting the rapid promotion of H. pylori.Diversification of 2C quality pipes in tandem: ColoClear, Pupu Tube and UU Tube have excellent profitability performanceIn the first half of 2022, all the three marketed products demonstrated excellent profitability, with the gross margins of ColoClear and Pupu Tube continuing to increase significantly compared to the same period in 2021. As of June 30, 2022, the gross margin of ColoClear reached 75.7%, the gross margin of Pupu Tube reached 80.0% and the gross margin of UU Tube reached 90.0%. Compared to the same period in 2021, the gross margins of ColoClear and Pupu Tube were 56.6% and 59.0%, respectively.The Company's sales volume of the core pipeline increased steadily in the first half of 2022, and the new pipeline continued to make efforts to take advantage of the favorable macro and micro home inspection policies in the first half of the year with "Resilient" marketing and firmly implementation. The high gross margin of the three products benefited from the Company's continuous and in-depth diversified business strategy, which optimized the pipeline mix for product sales, increased the revenue of single test for direct-to-consumer pipelines and brought about scale production through operational leverage benefits, which further reduced the operating cost of a single test.In the first half of the year, the Company has been making progress online and offline, both inside and outside the hospital. As of June 30, 2022, the Company has completed access and sales to over 800 hospitals in the first half of the year. During the "618" period, New Horizon Health continued to be the champion in sales of JD in three categories: medical devices, consumer medical and genetic testing. UU Tube won the top selling category of Tmall test paper. The Company's total sales in JD and Tmall exceeded RMB40 million, representing a 400% increase in total sales compared to the same period in 2021, and a 300% increase in sales of ColoClear YoY.Based on the mainland market, start international marketing: ColoClear debuted in Hong Kong and will advance to Southeast Asia in phases2022 is a milestone year for the internationalization of New Horizon Health. On May 23rd, the Company and Prenetics (Nasdaq: PRE) made a joint announcement that the two parties have launched in-depth cooperation to fully integrate the quality resources in market and pipeline development and product and service operation, and jointly promote the market coverage of ColoClear in Hong Kong, Macau and Taiwan, China, and explore the market opportunities in countries or regions in Southeast Asian at the same time. On June 8, ColoClear by Circle was officially launched in Hong Kong with an official price of HK$3,000. During the cooperation period, ColoClear is the colorectal cancer early screening product that Prenetics has exclusively partnered with.At the same time as ColoClear's debut in the Hong Kong market, New Horizon Health announced the establishment of the Company's first international R&D center in the Hong Kong Science and Technology Parks to attract global talent and focus on multi-omics cancer screening technology innovation and product development, including NGS, and to drive overseas commercialization and synchronized global clinical trials.About New Horizon HealthFounded in 2015, New Horizon Health is a pioneer and leader in China's cancer screening market, focusing on early home screening of high-incidence cancers, aiming to promote innovation in cancer screening technology and accelerate the popularity of cancer screening technology in China. On February 18, 2021, New Horizon Health was successfully listed on the SEHK with stock code 6606.HK, which became "the first listed Chinese cancer early screening company".New Horizon Health has three marketed products. ColoClear, Pupu Tube and UU Tube have all been approved by the National Medical Products Administration of China and are officially commercialized. ColoClear is the only cancer screening product approved by the National Medical Products Administration of China for people aged 40-74 who are at high risk of colorectal cancer. UU Tube is the only consumer self-test product for Helicobacter pylori approved by the National Medical Products Administration of China. Pupu Tube is the first FIT at-home self-test device approved in China. In addition, the Company has three pipelines of products in development for liver cancer (LiverClear), cervical cancer (CerviClear ) and nasopharyngeal cancer screening. The Company has global rights to all of its marketed and pipeline products. New Horizon Health works extensively with hundreds of hospitals, health check-ups, insurance companies, pharmacies and online channels. The Company has a class 100,000 clean production workshop that meets ISO13485 and ISO9001 international certification standards. The third parties medical testing laboratories in Beijing, Hangzhou and Guangzhou have been certified by international quality standards and the local health care commission and issued licenses to practice, with an annual testing capacity of 2 million people.(1) Excluding equity incentive-related expenses Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Eisai Publishes Potential Economic Value of Investigational Lecanemab in Peer-Reviewed Neurology and Therapy Journal

TOKYO, Jun 22, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its investigational anti-amyloid-beta (Abeta) protofibril antibody lecanemab in people living with early Alzheimer's disease (AD) using a validated disease simulation model, AD Archimedes Condition Event (AD ACE) model1,2,3 from the healthcare payer and societal perspectives in the United States, in the peer-reviewed journal Neurology and Therapy. This is the second publication of lecanemab's potential value. It follows the evaluation of the long-term health outcomes using simulation modeling of lecanemab published in Neurology and Therapy in April 2022.4 While the healthcare payer perspective focuses on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., productivity loss and informal care costs). As reported in the previous publication, it was suggested that compared to standard of care* (SoC), individuals treated with lecanemab in addition to SoC (lecanemab+SoC) may potentially experience slower disease progression to mild, moderate and severe AD from baseline by 2.51, 3.13 and 2.34 years on average, respectively. The preliminary results of this model-based simulation could possibly translate into additional quality-adjusted life years (QALY**) and reduction in the formal and informal care costs***. Additionally, the AD ACE model framework used in this study allowed assessment of the potential value of lecanemab in different scenarios and sensitivity analyses, including the impact of patient subsets, alternative treatment stopping rules**** and potential dosing regimens as well as major sources of uncertainty. Eisai is committed to conducting and sharing these types of clinical and socioeconomic analyses to establish trust as we work to potentially bring lecanemab to people living with early AD who have confirmed presence of amyloid pathology in the brain. To that end, Eisai would like to provide a common foundation for stakeholders' discourse regarding the potential clinical and socioeconomic value of lecanemab from the societal perspective, not to assign a price for lecanemab at this time. This model-based simulation was conducted using the results of a Phase 2b clinical trial (Study 201) evaluating the efficacy and safety of lecanemab for early AD with confirmed amyloid pathology as well as published literature. It also estimated the potential economic value of lecanemab+SoC over a broad range of willingness-to-pay thresholds from $50,000 to $200,000 per QALY gained as recommended by the Institute for Clinical and Economic Review (ICER)*****. Lecanemab+SoC was predicted to result in a gain of 0.61 QALYs and a decrease in total non-treatment costs of $8,707 per person from the healthcare payer perspective (Societal perspective: 0.64 QALYs gain and $11,214 decrease) compared to the SoC for patients with early AD who have confirmed presence of amyloid pathology. The potential annual value-based price (VBP) of lecanemab was estimated at $9,249 to $35,605 (Societal perspective: $10,400 to $38,053) based on this early economic assessment. ICER's value framework5 indicates that value cannot be wholly derived from measures of clinical and cost-effectiveness, so contextual considerations and an examination of other benefits and disadvantages are also added into the framework when assessing long-term value. This may lead to using the societal perspective and higher end of the broad range of willingness-to-pay threshold in estimating the justifiable price of lecanemab, given the large societal burden of AD relative to direct healthcare costs. Many people living with AD received informal care from their family and friends totaling more than 16 billion hours of unpaid care valued at $271.6 billion in the U.S. in 2021.6 These predicted and simulated findings suggest that early treatment with lecanemab may reduce these costs and economic burdens, and provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. The Phase 3 lecanemab Clarity AD data will soon be available to inform the model inputs and refine the findings. In the event that lecanemab receives the U.S. Food and Drug Administration's (FDA) approval, Eisai may determine a VBP using this framework along with other considerations, such as affordability, health system sustainability, etc. "Eisai's goal is to create therapies, such as our investigational anti-amyloid beta protofibril antibody lecanemab, that may help impact the anxieties of people living with Alzheimer's disease and their families. For Alzheimer's disease, it is important to evaluate the holistic value of therapies taking into account not only medical costs but also the immense societal costs," said Ivan Cheung, Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd., Chairman and CEO, Eisai Inc. "As part of Eisai's commitment to our human health care mission, trust and transparency, we will continue to publish data and information about lecanemab and look forward to sharing the results of the lecanemab confirmatory Phase 3 Clarity AD clinical trial this fall." Eisai completed lecanemab's rolling submission of a Biologics License Application (BLA) for the treatment of early AD to the FDA under the accelerated approval pathway in May 2022. The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The readout of the primary endpoint data of Clarity AD will occur in the fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during Eisai's fiscal year 2022, which ends in March2023. In Japan, in March 2022, Eisai initiated submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the goal of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022. Also, in Europe, based on the results of the Clarity AD study, Eisai plans to submit a new drug application in fiscal year 2022. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval. * Standard of Care (SoC) for AD currently consists of lifestyle modifications and pharmacologic treatment of symptoms.** The quality-adjusted life year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life (i.e., quantity) and quality of life (QOL), the QALY was developed as an attempt to combine the value of these attributes into a single index number. One QALY equates to one year in perfect health. QALY scores range from 1 (full health) to 0 (dead). For example, a new intervention may increase length of life by 3 years and improve quality of life by 70% (QALY score of 2.1) compared to an existing intervention that may increase length of life by 3 years and only improve QOL by 50% (QALY score of 1.5), the incremental QALY for this new intervention will be 0.6 QALYs.*** Formal and informal care costs do not include lecanemab drug cost.**** Alternative treatment stopping rules were explored in scenario analyses where treatment with lecanemab was stopped after a fixed duration of 1.5, 3 and 5 years.***** ICER is a non-profit research organization in the U.S. that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices and health system delivery innovations. 1 Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: Development and validation. Alzheimers Dement (NY). 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.001.2) Tafazzoli and Kansal. Disease simulation in drug development, External validation confirms benefit in decision making. The Evidence Forum. 2018. bit.ly/3NgEeDD(3) Tafazzoli A, Weng J, Sutton K, et al. Validating simulated cognition trajectories based on ADNI against 436 trajectories from the National Alzheimer's Coordinating Center (NACC) dataset. 11th edition of Clinical Trials on 437 Alzheimer's Disease (CTAD); Barcelona, Spain: 2018.(4) Tahami Monfared AA, Tafazzoli A, Ye W, Chavan A, Zhang Q. Long-Term Health Outcomes of Lecanemab in Patients with Early Alzheimer's Disease Using Simulation Modeling. Neurol Ther 11, 863-880 (2022). https://link.springer.com/article/10.1007/s40120-022-00350-y.(5) ICER Value Framework 2020-2023. 2022. bit.ly/39HjYO3(6) Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures 2022 Available from: bit.ly/3bkCR9VMedia Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Eisai Inc. USLibby HolmanLibby_Holman@Eisai.com201-753-1945 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Eisai to Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State (DSE) Symposium, and Other Pipeline Assets at the AD/PD 2022 Annual Meeting

TOKYO, Mar 11, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the company will present research from its robust Alzheimer's disease (AD) pipeline, including the latest findings on lecanemab, Eisai's investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early AD at the AD/PD 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) from March 15-20 in Barcelona, Spain and virtually. The lecanemab data and additional research findings from Eisai's clinical development programs will be featured in 13 presentations. Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the first quarter of Eisai's fiscal year 2022, which begins April 1, 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. "Four key presentations at AD/PD 2022 advance our understanding of the mechanism of action of Eisai's investigational anti- Abeta protofibril antibody lecanemab and the therapy's clinical and safety profile, including amyloid related imaging abnormalities, or ARIA, from the Phase 2b study and open-label extension, in the potential treatment of early Alzheimer's disease," said Michael Irizarry, M.D., Senior Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "In addition to lecanemab, Eisai's robust pipeline includes compounds targeting the tau pathway, other pathways leading to neurodegeneration, and the testing of combination therapies that may be the optimal approach to treat or even prevent Alzheimer's disease." The focus on AD has historically been on alleviating cognitive, functional, and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease. Eisai's investigational pipeline aims to treat the range of underlying pathophysiology, including amyloid, tau and neurodegeneration. "Because of the robust design of the lecanemab Phase 2b study, Eisai was able to design the Phase 3 confirmatory Clarity AD clinical trial to optimally verify lecanemab's clinical efficacy and safety in early Alzheimer's disease," said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd. "Part of the recruitment strategy for the Clarity AD confirmatory trial was to ensure greater inclusion of ethnic and racial populations. While there is still important work to be done in ensuring minority populations' participation in clinical trials, Eisai is proud that approximately 25% of the total U.S. enrollment in Clarity AD consists of African American and Hispanic persons living with early Alzheimer's disease, which mirrors the U.S. Medicare population." This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.For more information, visit https://www.eisai.com/news/2022/news202218.html. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation

TOKYO, Dec 24, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early Alzheimer's disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA. In September 2021, Eisai initiated a rolling submission to the FDA of a Biologics License application (BLA) for lecanemab under the accelerated approval pathway. The BLA is primarily based on clinical, biomarker and safety data from the Phase 2b clinical study (Study 201) in people with early AD and confirmed amyloid pathology, and non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and CMC) have already been submitted. The lecanemab Phase 2b study results demonstrated a high degree of Aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit. The lecanemab Clarity AD Phase 3 clinical study in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD is included to support the ongoing rolling submission. Another Phase 3 clinical study, AHEAD 3-45, is evaluating the efficacy of treatment with lecanemab in participants with preclinical AD and elevated amyloid and in participants with early preclinical AD and intermediate amyloid. Additionally, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Alzheimer's Disease is a serious, progressive and devastating disease with few treatment options. Eisai and Biogen are committed to bring new treatment options to people living with early AD, their families and healthcare professionals who are waiting for them as early as possible. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Better training, career progression for early childhood educators among new initiatives to boost pre-school quality

SINGAPORE - Efforts to lift the quality of pre-schools here will get a boost as improvements to training and career progression opportunities for early childhood educators were announced on Saturday (Oct 16). There will also be more support for kids from low-income families to encourage early pre-school enrolment and regular attendance. Minister for Social and Family Development Masagos Zulkifli announced the new initiatives at the Early Childhood Conference 2021 on Saturday and encouraged educators and pre-school operators to work together in training and development. He also launched the Skills Framework for Early Childhood following a review of the original 2016 version. The review was done by the Early Childhood Development Agency (ECDA), in collaboration with SkillsFuture Singapore, pre-school representatives and stakeholders. The new framework spells out the career pathways and competencies required for various job roles in the early childhood education sector. In particular, the career pathways have been expanded to reflect the potential progression and development available for educators teaching children in the younger age groups of two months to four years old, and the leadership career pathway now has new job roles such as deputy centre leader and pedagogy specialist. Said Mr Masagos: "This provides greater clarity on the progression and development pathways for educators in the early years, as well as new leadership roles that educators can aspire towards." There are also new career pathways for learning support educators and early intervention educators, reflecting ECDA's continued efforts in advancing inclusion in pre-schools. The framework can help interested individuals assess their career suitability and identify the required training for entry into the sector, said ECDA, adding that opportunities for professional development and career progression are important factors for retention. It said: "As the sector adopts the refreshed skills framework and puts in place the expanded career pathways, we expect the salary of early childhood educators to grow in tandem with the improved skills, larger responsibilities and more complex job roles required." A Continuing Professional Development Roadmap will also be rolled out progressively from 2022, it added. Mr Masagos announced that from December, families under the KidStart programme will get yearly top-ups to the Child Development Accounts. This is funded by contributions from corporate and community partners. KidStart supports parents by helping to provide them with the knowledge and skills to nurture their children's early development and over 2,000 children have participated to date. It runs programmes for children and parents. Children who are aged four or younger when they enrol in pre-school will receive $200 in the first year and subsequently $100 for each year of regular attendance till age six. Those above age four at enrolment will receive $100 yearly. More on this topic   Related Story Early childhood pilot programme KidStart grows to become non-profit entity   Related Story More financial support for pre-school children from low-income families "We want to enable every child to have the best chance to flourish in life, regardless of their family background or resources," said Mr Masagos. ECDA said the move is meant to encourage families to enrol their children in pre-school early and have regular attendance in KidStart programmes and at school. The money given is on top of the Government's recent announcement of a one-off $200 top-up for all Singaporean children aged six and below. Mr Masagos also announced that pre-appointment training for inclusion coordinators in pre-schools will begin from end-2021. It was announced earlier this year that every pre-school would have to appoint one staff member as an inclusion coordinator from the second half of 2023. More on this topic   Related Story Need for more teacher training and less stigma as demand for inclusive pre-schools grows   Related Story Demand for inclusive pre-schools in S'pore grows as more are aware of benefits ECDA has been pushing for more inclusion in pre-schools in recent years and pre-schools have followed suit. For example, Presbyterian Community Services has partnered the philanthropic organisation Chua Foundation to increase capacity and care for children with special needs through a new programme. Presbyterian Community Services, which runs 11 pre-schools islandwide, aims to increase the number of places for these children from the current 50 to 220 by 2025. On Saturday, Mr Masagos also launched the Early Childhood Digitalisation Grant to support the adoption of digital solutions by pre-schools. More than $4 million will be available over the next three years to help pre-schools defray the cost of adopting pre-approved digital solutions. "Pre-schools can also look out for new solutions to help them e-enrol children and use data analytics to make our pre-schools run better," he said. More on this topic   Related Story Parents say all children benefit from inclusive pre-schools, have better social skills   Related Story More financial support for pre-school children from low-income families

Topelia Australia launches US$25M Series A call for COVID-19 ATT Ziverdox

SYDNEY, Oct 14, 2021 - (ACN Newswire via SEAPRWire.com) - Topelia Australia, a biotech company established to commercialise a novel ATT treatment for Australians in quarantine, has launched an investment program designed to keep the invention Australian owned - while rolling out treatment to the world.Prof Thomas Borody- Topelia announces US$25 mil Series A capital raise to fund manufacture and clinical trials of the COVID-19 Antiviral Triple Therapy (ATT).- Topelia has secured exclusive global patent rights to COVID-19 Antiviral Triple Therapy from Prof Thomas Borody.- Borody's track record includes effective treatment for Peptic Ulcers & Crohn's Disease, recolonisation of bowel microbiome, and 3 FDA approved drugs on the market.- Based on current research, the ATT provides an inexpensive and medically efficacious treatment for the prevention and early treatment of COVID-19.The company is raising USD$25 million from investors in Australia, Asia and USA. The company said: "Topelia proposes to offer the ATT treatment alongside the current vaccination program to treat and vaccinate our way out of this pandemic. As Australia comes out of lockdowns and countries around the world experience spikes in cases, it is vital to fast-track the production of a safe early antiviral medical treatment kit.The novel Antiviral Triple Therapy, to be branded as Ziverdox, comprises TGA-approved medications prescribed for decades with exceptional safety profiles. COVID-19 will be with us for some time so even vaccinated people with breakthrough Covid-19 infections can benefit from ATT to prevent long-COVID associated lung, brain and organ damage."The company says it is pleased the Australian Government is supportive of early at-home treatments. The Government has recently invested in an experimental early antiviral drug candidate which may be available early next year if the safety profile and clinical research allows for TGA approval.Purpose of proposed Series A fundingThe investment will finance:- Preparation of a Literature-Based Submission to the TGA to gain approval;- Clinical trials to prove efficacy of both treatment and prevention regimens;- Sourcing of ATT components and manufacture of compliance enhancing packaging;- Liaison with the TGA for marketing approval including TGA fees, consultant fees, scale-up of manufacturing and distribution costs;- Following TGA approval, product launch costs for the ATT pack called Ziverdox.About Topelia Aust Pty LtdTopelia Australia was founded based on the wealth of experience in commercialising the ground-breaking triple therapy cure for peptic ulcers which has saved over 18 thousand lives in Australia alone. This innovation has also saved the Australian Government more than $10 billion in medical costs associated with peptic ulcer surgery and hospitalisations. Professor Borody has more than 190 patents and applications, 3 FDA-approved drugs on the market, and more than 300 peer-reviewed papers published. Topelia Australia owns the patent rights to the novel Antiviral Triple Therapy. Visit https://TopeliaAustralia.com.Media contact: Info@TopeliaAustralia.comInvestor contact: Investor@TopeliaAustralia.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

TOKYO, Sep 28, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company's investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (early AD). The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology. The lecanemab Phase 2b trial results demonstrated a high degree of Abeta plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit. AD is a serious, progressive and devastating disease with few treatment options. Eisai is utilizing the accelerated approval pathway after discussion with the FDA and aims to bring a new treatment option to people living with early AD, their families and healthcare professionals.In June, 2021, lecanemab was granted Breakthrough Therapy designation, which is an FDA program intended to expedite the development and review of medicines for serious or life threatening conditions. Eisai has an agreement with the FDA to submit the BLA for lecanemab as a rolling submission. This agreement allows completed portions of the application to be submitted to the FDA for review on an ongoing basis. After all portions are submitted to the FDA and the agency accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set.The BLA submission for lecanemab is primarily based on the results of the proof-of-concept Study 201 in 856 patients with mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology. The results were published in a peer-reviewed journal in April 2021.1 Study 201 explored the impact of treatment with lecanemab on reducing brain Abeta and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. Furthermore, the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer's Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. The rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with amyloid targeted therapies, for the 10 mg/kg biweekly dosing was 9.9%.After completion of the Core period and a Gap period off treatment (average of 24 months), all 180 patients in the Study 201 open-label extension study received 10 mg/kg biweekly lecanemab dosing. The data confirmed lecanemab produces reductions of amyloid PET SUVr, with significant reduction occurring as early as 3 months, and >80% of subjects achieved amyloid negative status by visual read in as early as 12 months [https://www.eisai.co.jp/ir/library/presentations/pdf/e4523_210730.pdf]. Significant amyloid reduction relative to placebo in those exposed to lecanemab in the Core period was maintained while off-treatment over the Gap period. The rate of ARIA-E was consistent with the Core study at around 10%.The lecanemab Clarity AD Phase 3 clinical trial in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The U.S. FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD will be included to support the BLA."With the worldwide population growing and aging, the number of people living with AD is on the rise. AD imposes an enormous burden on not only people living with AD and their families but also for society. We recognize the strong and urgent expectations from stakeholders to further advance a treatment system for this disease. For many years, Eisai has endeavored to understand the anxieties of people living with AD and has been conducting research and development of novel therapies," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "The lecanemab rolling BLA submission marks a new milestone toward the advancement of a treatment system for AD. As part of our human health care mission, we are committed to bringing new medicines to people living with AD and their families as early as possible.""The Alzheimer's community welcomes scientific innovation that creates more treatment options for people living with this terrible neurodegenerative disease," said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, University of Nevada Las Vegas. "Based on the efficacy and safety results of the Phase 2b study and preliminary results from the open-label extension study, I am optimistic about the potential lecanemab may have as a treatment choice for patients with early Alzheimer's to ameliorate the otherwise inevitable decline they face.""It is our vision that patients and their families have choice and access to multiple treatment options for Alzheimer's disease. The rolling submission of lecanemab for FDA review under the accelerated pathway is a positive step toward that goal," said Michel Vounatsos, Chief Executive Officer at Biogen. "We believe that treatments directed at amyloid beta reduction in the brain have the potential to transform diagnosis and treatment of Alzheimer's disease. We look forward to continuing to work with Eisai to pioneer science, advance knowledge, and serve the needs of Alzheimer's patients."MEDIA CONTACT:Eisai Co., Ltd.Public Relations Department TEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman +1-201-753-1945 Libby_Holman@eisai.comINVESTOR CONTACT:Eisai Co., Ltd.Investor Relations Department TEL: +81-(0)70-8688-9685MEDIA CONTACT: Biogen Inc.Allison Parks +1-781-464-3260public.affairs@biogen.comINVESTOR CONTACT: Biogen Inc.Mike Hencke +1-781-464-2442 IR@biogen.comFor more information, visit https://www.eisai.com/news/2021/pdf/enews202177pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Golf: Americans storm back into contention at Solheim Cup

TOLEDO (REUTERS) - The United States won three of its four matches during Sunday's (Sept 5) early session of foursomes to pull within one point of Europe at the Solheim Cup at Inverness Club in Toledo. The home side's nightmare start to Saturday's first round looked like it would repeat itself on Sunday as the Europeans jumped out to an early lead in all four matches on the front nine. But the United States got hot on the back nine and Jennifer Kupcho drilled a series of clutch putts to secure the win with Lizette Salas, giving the throngs of enthusiastic US golf fans something to cheer about. "I definitely live for this," Kupcho said. "It's super fun to hear the crowd roar. It's super exciting for me and I love the sound of it. "So I'll keep doing it, hopefully," she said with a laugh. Four ball matches are underway in the afternoon session. The three-day competition is expected to draw more than 100,000 fans and is scheduled to wrap up on Monday, the Labour Day holiday in the United States. The Americans lead the overall series 10-6. More on this topic   Related Story Golf: Europe take early lead over US at the Solheim Cup   Related Story Golf: Nelly Korda, women's Open winner Anna Nordqvist qualify for Solheim Cup

Queues form early for free masks on morning of Temasek Foundation’s fifth distribution exercise

SINGAPORE - People began queueing for free masks early on Thursday morning (Aug 26) as Temasek Foundation kicked off its fifth Stay Prepared initiative. Each household can collect 50 medical-grade surgical masks and 25 N95 respirator masks at selected malls and supermarket outlets islandwide from Thursday to Sept 26. The exercise was announced earlier this month and initially scheduled to start after National Day. However, it was pushed back to Aug 26 to give participating organisations more time to test the distribution system. On Thursday morning, over at Lot One shopping mall in Choa Chu Kang, signs were placed in the mall to direct people to a collection point at the customer service counter on the second floor. Some people began queueing for the masks before 10am, and mall staff could be seen directing the early birds to come back later, or to scan a QR code and join a virtual queue. One such early bird was retired typist Madam Tan, who arrived at the mall around 9.30am. "I came because (I thought) people may be kiasu, I was worried people would come and queue early," said the retired typist, who declined to give her full name. She said that when she had previously tried to collect free Vitamin D supplements during Temasek Foundation's distribution exercise in March this year, supplies had run out by the second day, so she thought it best to arrive early for this month's mask distribution exercise. Other seniors in the queue could be seen telling one another about their experiences with previous distribution exercises and why they were staying to wait. Retired seamstress Chong Fong Xing, 71, said she felt the distribution exercise was a convenient way for people to get their masks. "The staff told us to go home and come back later, but it's troublesome, so we might as well stay here," she said, adding that she was happy to wait. Meanwhile at Junction 8 mall in Bishan, the situation was less organised. Checks by The Straits Times found only one generic banner placed along the main walkway, with no clear instructions on where people should go to pick up the masks. Most of those in line were seniors, some of whom were unhappy about having to wait to collect their masks. Retiree Mr Low, 68, said he felt that communication about where to collect the masks had been poor. He added that staff should have been more flexible about allowing people to collect the masks before the 11am collection time. More on this topic   Related Story askST: What is a mask with 'higher filtration capability' and how do I select one?   Related Story How often do you wash your mask? This is how a mask worn for 6 hours looks like "The majority of us are senior citizens. There are at least 10 of us here now... Why can't they let us collect the masks? The (staff member) is already waiting at the counter. "Have some discretion, flexibility and compassion for people. If we come early, let us collect the (masks)," he said, adding that a majority of those in line were retirees going for their morning shopping. Additional reporting by Timothy Goh

New Horizon Health Announces 2021 Interim Results: Revenue Increases 317% Year-on-year, Gross Profit Margin Climbs to 56.2%

HANGZHOU, Aug 21, 2021 - (ACN Newswire via SEAPRWire.com) - New Horizon Health (6606.HK) (the "Company"), the first public listed cancer screening company in China, has today announced its financial report for the first half year ended 30 June 2021.In the first half of 2021, the Company's total revenue was RMB43.9 million, a year-on-year increase of 317%. Gross profit was RMB24.7 million, up 1,000.2% from the same period of 2020. Gross profit margin also climbed from 21.3% in the same period of 2020 to 56.2%.ColoClear, the first and only molecular cancer screening test approved by National Medical Products Administration (NMPA) in China, realized revenue of RMB14.2 million in the first half of 2021, an increase of 149% year-on-year. Its shipment volume was about 121,500 units in the first half of the year, a rise of 392% over the same period last year, and its gross profit margin increased from 33.9% in the same period of 2020 to 56.6%. Pupu Tube, the first and only self-conducted fecal immunochemical test (FIT) screening product approved by NMPA in China, recorded revenue of RMB29.6 million in the first half of 2021, representing year-on-year growth of 623.7%. The product's gross profit margin also increased from 26.4% in the same period of 2020 to 59.0%.The latest report issued by the International Agency for Research on Cancer (IARC) predicts that new cases of breast cancer and colorectal cancer around the world will increase the most in the next 50 years. The penetration rate for colorectal cancer screening in China was only 16.4% in 2019, while that in the United States reached 60.1%. The social and economic value of early cancer screening has quickly received attention and recognition from various domestic sectors in 2021, and the market is entering the fast lane at full speed.Mr. Yeqing Zhu, Executive Director and CEO of New Horizon Health, said, "The year 2021 marks the first year for the regulation, innovation and evolution of China's early cancer screening industry. As progress relies on strength, New Horizon Health has just opened a new chapter of growth. The strong sales growth of ColoClear and Pupu Tube proves that home-based cancer screening tests have successfully gained recognition from target groups and addressed the urgent needs of consumers in upgrading their health. The improvement in gross profit margin was driven by the rapid and determined execution of our diversified commercial layout in the first half of the year, which significantly increased the average selling price of both products. The higher sales volume has also enabled more efficient management of our operating facilities, further reducing our unit operating cost."Mr. Zhu added, "The recognition from clinical experts and doctors is the cornerstone of our market expansion and product development. In January and April this year, the Company's proprietary multi-target stool-based FIT-DNA test technology was included within the first national 'Guidelines for Prevention and Treatment of Colorectal Cancer' and 'Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines' initiated by the National Cancer Center of China. The FIT-DNA test is the only molecular cancer screening and genetic testing technology presently included in national guidelines. Meanwhile, our marketing team has also expanded by 137% to 270 people in the first half of 2021. The launch of ColoClear to public hospitals across various provinces and cities has progressed smoothly. As a pioneer and leader in cancer screening in China, we are committed to investing in awareness and compliance education for cancer screening. Pupu Tube, an entry-level product for home-based self-testing for cancer detection costing less than RMB100 per unit, has become the vanguard of market education and sinking the vast grassroots. In the second half of the year, we will continue to build up our professional team structure and strengthen our cooperation and promotion with medical check-up centers, insurance organizations, online medical consultation platforms, pharmacies, and other authorized institutions. ColoClear will soon see an explosion of promotion".Continues to promote early cancer screening compliance advantages and build a diversified business presenceThe "First Certificate for Early Cancer Detection in China" approved by the NMPA of China on 9 November 2020 has set a benchmark for compliance in the cancer screening industry. Capitalizing on its advantageous position as the first cancer screening compliant company in China, after its successful listing in Hong Kong, New Horizon Health has quickly established in-depth strategic partnerships with leading brands across several sectors. Such cooperation accelerated the implementation of diversified business presence and promoted ColoClear and Pupu Tube to become the exclusive promotional products of various strategic cooperation platforms.The cooperation with AstraZeneca China has strongly supported the Company's expansion into China's digestive disease prevention and treatment sector and consolidated its advantages in the in-hospital clinical market. The partnership with JD Health has realized the in-depth alignment of the platforms of New Horizon Health and JD.com and the Company's user service system, an important step forward for its conducting e-commerce marketing. While the cooperation with Ping An Healthcare has enabled the first closed-loop solution integrating Internet medical and healthcare in China, marking a major advance from online diagnosis and treatment to cancer prevention and screening. The cooperation with China Post has filled the gap in intestinal screening, and cancer prevention and treatment in China's grassroots market while educating the user in the vast township market. The partnership with PICA Health has empowered three million village doctors to promote intestinal health and prevent intestinal diseases in remote rural areas with severe deficiencies of diagnosis and treatment resources and shortage of colonoscopy equipment.The only stool-based FIT test included in two medical guidelines and commercialized to clinical markets Hospital market access and clinician education are the keys to the promotional efforts to hospitals for New Horizon Health. The multi-target stool-based FIT-DNA testing technology developed by New Horizon Health has become the sole colorectal cancer screening and DNA test technology recommended by two medical guidelines in January and April 2021: The "China Guidelines for the Screening, Early Detection and Early Treatment of Colorectal Cancer" was compiled by the National Health Commission and published by the National Cancer Center; and the latest edition of the "Guideline for Diagnosis and Treatment of Colorectal Cancer" was published by the Chinese Society of Clinical Oncology (CSCO).With the implementation of colorectal cancer early screening standards and regulations, negative predictive value (NPV) and sensitivity have become the industry standards for the selection and performance evaluation of early cancer screening products. New Horizon Health's clinical team has aggressively conducted a series of academic seminars and clinical trials to continuously promote the multi-target stool-based FIT-DNA testing technology into the existing clinical segment and implement the technology into the practice and application of clinically-related fields. Striving its utmost to invest in popular science education for early cancer screening in multiple formats across platforms and in pursuit of continuous innovation As a leader in the early cancer screening industry, New Horizon Health has always adhered to spare relentless effort in investing in market education. In the first half of the year, New Horizon Health continued to promote early cancer screening education to the general public.On 15 April 2021, the Committee of Colorectal Cancer of the Chinese Anti-Cancer Association and the People's Daily Health App co-launched China's first-ever "Early Cancer Screening Day" during the "Nationwide Promotion Week for Popular Science Education on Oncology", making early cancer screening an important event in China's strategic public health campaign. Subsequently, New Horizon Health has organized its first branded health awareness day with the theme of "Changing Life Trajectory" inviting seven industry national clinical experts. The live streaming of the event recorded 5 million views. During the 618 Festival, New Horizon Health teamed with Kuaishou Health and Xiaohe Health to launch a popular science short video campaign featuring intestinal health, early screening, and cancer prevention. More than 80 million views were recorded by the two platforms. During the same period, New Horizon Health ranked No. 1 in industry sales in the DNA test category segment and in sales of a single product on JD.com as well as No. 1 in terms of spending in the healthcare product list on 18 June.R&D pipeline progresses as planned, while overseas cooperation and business expansion focuses on building future pipeline capacityThe approval of the UU Tube is progressing on schedule, and preparations for the kickoff of the clinical trial of CerviClear is proceeding smoothly. New Horizon Health is accelerating its R&D in multiple product pipelines, and has heavily invested in the development of biomarker R&D capability for, and the building of, the next-generation sequencing technology platform. The Company continues to make additional investments, expand automated production lines, and enhance production and testing capabilities to meet the fast-growing demand.Moreover, New Horizon Health has officially commenced overseas strategic cooperation, actively introducing advanced technologies and focusing on future new pipeline layout and capacity expansion. The listed company New Horizon Health contributed US$30 million to the establishment of NHH Venture Fund, L.P. Fundraising for the first phase of the Fund was completed on 20 August 2021. The Fund is to focus on investing in molecular diagnostic technology to promote disease screening and early testing for cancer and other serious diseases. In July 2021, New Horizon Health and Proteomedix have forged a partnership for R&D cooperation and investment in its convertible debt. In addition, in August 2021, New Horizon Health and Epigenomics AG have signed an asset purchase agreement.About New Horizon Health Founded in 2015, New Horizon Health is the pioneer and market leader in China's cancer screening sector focusing on early detection of high-incidence cancers at home. It aims to promote innovation in cancer screening technology and expedite the widespread take-up of cancer screening technology in China. On 18 February, 2021, New Horizon Health was successfully listed on the Stock Exchange of Hong Kong under the stock code of 6606.HK, becoming the "first cancer screening stock in China".New Horizon Health's two colorectal cancer screening products, ColoClear and Pupu Tube have been approved by the National Medical Products Administration (NMPA) and have commercialized. ColoClear is the first and only cancer screening product approved by the NMPA in China. In addition, the Company also has two pipeline candidates for gastric and cervical cancer screening respectively. The Company holds global rights in all its marketed and pipeline products. New Horizon Health has a 100,000-grade clean production workshop accredited with ISO13485 international certification, and third-party medical laboratories in Beijing, Hangzhou and Guangzhou, that are certified and licensed to practice by the local Health Care Commission, with an annual testing capacity of 2 million samples, and extensive cooperation with hundreds of hospitals, medical check-up centers, insurance companies, pharmacies and online channels. Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

Football: Mbappe on target as PSG win without Messi and Neymar

PARIS (AFP) - Kylian Mbappe and Angel di Maria were both among the scorers as a Paris Saint-Germain side missing both Lionel Messi and Neymar won 4-2 away at Brest on Friday (Aug 20) to make it three wins out of three this season in Ligue 1. Ander Herrera and Idrissa Gana Gueye also found the net for the capital side as they moved ominously on to nine points from a possible nine and clear at the top of the fledgling French table with a second consecutive 4-2 victory. The full house of 15,000 in Brittany were denied the chance to see Messi make his PSG debut after the Argentine was left out of the squad as he continues to build up his fitness. Neymar, who like Messi returned to training late after going all the way to the final of the Copa America last month, was also left out but PSG once again showed that they have little trouble finding the net and winning without the two superstars. However, once again their defending left a lot to be desired and will have given coach Mauricio Pochettino food for thought with a number of players still waiting on the sidelines. Donnarumma on the bench Italy's Euro 2020 goalkeeping hero Gianluigi Donnarumma appeared in the squad for the first time since his arrival from AC Milan but was left on the bench as Keylor Navas started in goal. Donnarumma's fellow European champion, Marco Verratti, did play for the first time this season in midfield but skipper Marquinhos was still missing. Mbappe has dominated headlines in Paris ever since the arrival of Messi as speculation surrounds the future of the World Cup winner, who is out of contract at the end of the campaign and is a target for Real Madrid. However he set up a total of four goals in the opening league wins against promoted Troyes and against Strasbourg, and once again Mbappe played a central role in the rudimentary surroundings of the Stade Francis-Le Ble. PSG went ahead midway through the first half when Mbappe tried a clipped cross which was cleared out to the edge of the area where Herrera met the ball on the volley and the Spaniard's shot found the bottom corner. Mbappe made it 2-0 in the 36th minute, arriving to head in his first goal of the season after Georginio Wijnaldum's shot had been blocked. Brest got one back just before the break when Franck Honorat finished first-time after a fine back-heel lay-off by Romain Faivre. More on this topic   Related Story Football: Messi left out of PSG squad for Brest game   Related Story Football: Lionel Messi launches 'Messiverse' NFT crypto art collection Nevertheless Gueye appeared to put the game to bed when he made it 3-1 in the 73rd minute with a piledriver from fully 35 metres which Brest's Dutch international goalkeeper Marco Bizot could only help on its way in. Yet Brest pulled another one back five minutes from time through Steve Mounie, with Faivre again providing the assist. PSG were actually in danger of conceding an equaliser until the 90th minute when, as Brest threw everyone forward, Di Maria broke downfield and played a one-two with Achraf Hakimi before scoring with a delightful lob. More on this topic   Related Story Football: Too early for Messi to take the field, says Pochettino   Related Story Football: Too early for Messi to take the field, says Pochettino Di Maria had come on for Mbappe late on for his first appearance of the campaign and his goal was reminiscent of his winner for Argentina in the Copa America final against Brazil last month. Saturday in Ligue 1 sees Monaco host Lens in between the two legs of their Champions League play-off against Shakhtar Donetsk, before defending champions Lille go to Saint-Etienne.

Kindergarten principal has no regrets giving up architecture five years ago

SINGAPORE - When 33-year-old Eudora Tan made the switch to early childhood education from architecture five years ago, there were many people who questioned her decision. She had spent five years studying to be an architect at the National University of Singapore, including completing a master's degree. "To them, architecture seemed like a profession that took me such a long time but I gave it up after just a few years of working," said Ms Tan. She found the work too demanding because of the long hours involved, and decided to try something different. "I've always had an opportunity to be with children in terms of like Sunday school in church or even with my nephews and that got me thinking - that I do like working with children," she said. In 2014, Ms Tan took the leap by taking a Diploma (Conversion) in Kindergarten Education - Teaching at Singapore Polytechnic. She joined St James' Church Kindergarten (Gilstead) as a maths teacher in 2015, and was promoted to principal in July this year. She received the Outstanding Early Childhood Teacher Award at the Early Childhood Development Agency Awards for Excellence in Early Childhood Development virtual ceremony on Saturday (Nov 28). "I just enjoy going to school, the children are just amazing. I simply love the conversations with them, they reveal their curiosities and their thought processes." Her training as an architect has been put to good use, said Ms Tan, who is married and has a two-year-old son. "Being an architect is not just about design but seeing a project through and thinking how to solve problems, and working through the details. "It has translated into how I work with children, by helping them to solve problems instead of just giving them the answers," she said. "I may not be designing a building but I am building the lives of the children, and that goes a long way." More on this topic   Related Story Despite early doubts, former nurse finds success working in pre-school   Related Story PCF Sparkletots to send 400 principals and curriculum specialists for NIE training

Despite early doubts, former nurse finds success working in pre-school

SINGAPORE - The sight and sound of infants laughing are among the reasons Ms Jacintha Jayadas looks forward to her work as an early childhood educator. The 27-year-old said even on weekends, when she is off, she misses the children. Ms Jacintha, who is single, now works at Tots and Teddies in Telok Ayer, after making the switch from nursing in 2017. Despite initial worries that she might not be able to handle the work, the nurse of two years feels more confident now in caring for infants aged two months to 18 months. This is due to guidance she received from senior teachers, principals and others, she said. Ms Jacintha, who has a diploma in counselling, is among 17 pre-school educators and eight centres to receive awards for Excellence in Early Childhood Development in a virtual ceremony held on Saturday (Nov 28). The awards are meant to highlight the professionalism of the early childhood sector and recognise outstanding and promising early childhood educators and centres, according to the Early Childhood Development Agency. Ms Jacintha received the Promising Early Childhood Educarer Award for her work in building relationships with the families of the children as well as the quality of her care for the infants. Among the centres that won awards is Chatsworth Preschool, which has two campuses here. It received the Early Childhood Innovation Award (Distinction) for its Language of Food project, which aims to cultivate responsibility during mealtimes. Its centre at Piccadilly Circus in Seletar got toddlers involved in a number of activities, from food preparation to cleaning up the kitchen space. It also customised and integrated the food pantry into the classroom, so that mealtimes could become part of the curriculum with children picking up skills such as language, numeracy and motor coordination. In a pre-recorded video for the ceremony, Minister for Social and Family Development Masagos Zulkifli said that the award winners showcase quality standards in teaching, caring, leadership and innovation in the early childhood sector. "But they are just the tip of the iceberg. Beyond the visible are thousands of educators who continue to give their best every day, inspiring, teaching, caring for, and nurturing our children," he noted. "I hope that all our early childhood professionals will continue to strive for excellence as a fraternity and cheer one another on, as we work towards a common goal of giving every child a good start in life," added Mr Masagos, who also said early childhood professionals are the heart of quality pre-schools. "A good educator makes a good pre-school, which produces happy and well-developed children," said Mr Masagos. Ms Jacintha Jayadas interacts with an infant in her care at Tots and Teddies pre-school in Telok Ayer. PHOTO: EARLY CHILDHOOD DEVELOPMENT AGENCY Ms Jacintha is currently enrolled in a part-time degree programme in Early Childhood Guidance and Counselling. She will graduate in March next year. "With training in counselling, I can help more children address problems or situations they may face," said Ms Jacintha. Her nursing experience has helped. When something happens, such as an accident or a fall, she is able to respond quickly. "I immediately know my next course of action, and I'm not afraid of blood or bruises, and I can think on my feet," said Ms Jacintha. More on this topic   Related Story Kindergarten principal has no regrets giving up architecture five years ago   Related Story PCF Sparkletots to send 400 principals and curriculum specialists for NIE training She enjoys her work as an infant educarer, as she feels it is at this stage in their lives where one can really make a difference. "I can contribute to the first step that they take, the first words they speak," she said. "I feel like I help the parents the most at the infant stage because many of them are first-time parents," added Ms Jacintha.

DETAK by Brawijaya University Researchers detects Heart Disease Early and Accurately

Malang, East Java, Indonesia, Nov 27, 2020 - (ACN Newswire) - Researchers from the Brawijaya University (UB) Medical School in Malang, East Java have developed DETAK, a smartphone application for patients with heart disease. The app works on an AI (artificial intelligence) algorithm, to provide early and accurate detection of heart disease, or acute coronary syndrome, and prevent delays in proper diagnose and treatment.Acute coronary syndrome describes a host of conditions linked to the sudden, reduced flow of blood to the heart. One such condition is a myocardial infarction, or heart attack, in which cell death results and can lead to damaged or destroyed heart tissue. DETAK was designed to prevent these types of occurrences with early discovery."Apart from functioning as an early detection tool encouraging patients to seek treatment, DETAK serves to remind heart disease patients to take their medication and undergo medical checkups regularly," noted Mohammad Saifur Rohman, the lead researcher of cardiovascular study at the UB Medical School. The application also offers informative articles on heart disease and advice for maintaining a healthy heart.Rohman drew attention to the importance of the early detection service in the application, since delay in the detection of heart disease is a main causal factors in the high number of heart attack cases resulting in death, citing data from the Dr. Saiful Anwar Hospital in Malang. He attributed this delay in detection mostly to a lack of knowledge and awareness of the symptoms of acute coronary syndrome.For early detection of the ailment, patients using the DETAK app answer several questions related to chest pain they experience and will be notified on where to go to seek help. The app will direct users with high risk of acute coronary syndrome to hospitals with cardiologists on duty, while those with low risk of acute coronary syndrome will be directed to visit nearby health facilities with general practitioners on duty.The DETAK application has already received the Indonesian Museum of Records (MURI) award, and will soon cover health facilities across Indonesia, with data collection in collaboration with the Indonesian Cardiologist Association (PERKI), Indonesian Medical Association (IDI) and other related facilities.For further information, contact:Universitas Brawijaya (UB) Public Relationswww.ub.ac.id and www.prasetya.ub.ac.id. Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com

More than 1,900 jobs available in early childhood sector; 8 in 10 for PMETs

SINGAPORE - More than 1,900 jobs are on offer in the early childhood sector, with eight in 10 for professionals, managers, executives and technicians (PMETs). They make up the bulk - 98 per cent - of the 1,940 jobs, traineeship and attachment openings available as at the end of September, said the Ministry of Manpower (MOM) in its weekly jobs situation report on Monday (Nov 2). The 1,620 PMET jobs include pre-school teachers, centre leaders and childcare services managers. Another 290 jobs available are for non-PMET roles. Apart from jobs, there are about 30 company-hosted traineeships and attachments available. "The operators do want to bring people on board, not necessarily just on traineeships and attachments, because they are confident that they have vacancies to fill," said Manpower Minister Josephine Teo at a virtual media conference. Her ministry disclosed that more than 570 people were placed into jobs, traineeships and attachments positions in the sector between April and mid-October, through the help of Workforce Singapore (WSG) and the National Trades Union Congress' Employment and Employability Institute (e2i). This is on top of direct recruitment by the operators themselves. With more dual-income families and working grandparents as well as greater emphasis placed on the importance of the early years for child development, preschool enrolment is expected to rise, driving the sector's labour demand, said MOM. Currently, there are about 21,000 certified educators in the early childhood sector here, up by over 30 per cent from 2016. Demand is expected to grow as pre-school places are set to rise to more than 200,000 by 2023. There are three main career tracks under the skills framework, developed by the Early Childhood Development Agency (ECDA), SkillsFuture Singapore and WSG with early childhood stakeholders. Educators under the leader track, who will take on centre or teacher leadership positions in both kindergartens and childcare centres, will earn between $3,100 and $7,600. Those on the teacher track, who will work with children between four and six years old, can earn $2,200 to $3,550. Educators on the educarer track, who work with children aged two months to four years, earn between $1,800 and $3,150. More on this topic   Related Story PCF Sparkletots to send 400 principals and curriculum specialists for NIE training   Related Story Pre-school teachers' career paths to be reviewed, more support for outdoor learning for children Jobseekers who wish to join the sector as educators must attain either an early childhood certificate or diploma offered by the National Institute of Early Childhood Development (NIEC), or programmes accredited by the ECDA and conducted by private training agencies. A certified early childhood course duration ranges between four months and 2.5 years for mid-career jobseekers. Those looking to make a mid-career switch to the sector may do so through the professional conversion programme (PCP) for preschool teachers and the place-and-train programme for educarers, which will equip them with the necessary skills and qualifications, said MOM. They may then register with ECDA as qualified pre-school teachers or certified educarers, and work in ECDA-licensed childcare centres and kindergartens respectively. Mrs Teo said the sector appreciates individuals who bring in transferable skills from outside the sector, noting that about three in four people in the early childhood scene have come from other sectors. More on this topic   Related Story At 46, she switched careers, moving from the retail sector to early childhood education   Related Story The changing profile of the Singapore worker and the challenges he faces amid Covid-19 job cuts She added that individuals with a good service orientation, such as those from the hospitality and retail sectors, are strong candidates. Besides the specialised roles that require jobseekers to meet prerequisites such as having an early childhood certificate or diploma, there are also ancillary roles that jobseekers can enter, such as in the areas of marketing, human resources, finance and administration. These roles would still provide jobseekers with a deeper insight into the sector, further paving their entry into it, should they wish to embark on the educator and educarer pathway, said MOM. "These roles also provide both industry-relevant skills and soft skills that can boost their chances of landing a job across other sectors." To attract and retain talent, the early childhood sector has worked with WSG to develop and roll out a 12-month Progressive HR Practices Early Adopter Programme, or Project JOY. More on this topic   Related Story How to make your resume stand out amid tough job market during Covid-19 pandemic   Related Story Retrenched SIA staff apply for jobs at EtonHouse Since November 2016, the programme has helped early childhood operators in shaping the early childhood sector as one with attractive career pathways for new entrants and existing talents. "Having more experienced and trained employees in the sector would also raise the quality of care and education for the next generation," said MOM. Under the programme, operators can apply for subsidies to undergo training in areas such as leadership communication, employee engagement, culture building and HR practices. HR personnel can also attend programmes that can help them better plan and develop training roadmaps to upskill their early childhood professionals and plug any skills gaps. To date, more than 135 operators, including Cherie Hearts, Skool4kidz, Learning Vision and Kidz Meadow, have participated in the programme, benefiting over 8,800 employees - or about 30 per cent of the early childhood workforce. Mrs Teo said such an initiative is important, "because the people who have invested their time in this sector do want to continue to grow, and there is always new knowledge to be gained about how we can help children develop their potential more effectively". More on this topic   Related Story More avenues for progression and training for teachers in special education schools   Related Story Mismatch in expectations leave many vacancies unfilled, say observers Speaking at the same press briefing, Minister for Social and Family Development Masagos Zulkifli said the sector has been "very resilient" in the midst of the Covid-19 pandemic, and is still growing and employing. The ECDA has been working closely with operators to accelerate hiring plans and place affected employees from sectors hard-hit by the pandemic, including stepping up efforts to reach out and place mid-career jobseekers through career conversion programmes. At the same time, the agency has been working with operators to provide about 500 short-term safe management assistant positions to implement safe management measures in the preschools. Those found to be suitable for permanent roles can also be placed on PCPs, where they undergo skills conversion to move into the sector. 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Blood test for early detection of gastric cancer being evaluated for use in primary healthcare

SINGAPORE - A blood test that can detect gastric cancer in its early stages has been developed and is currently being evaluated for use in hospitals and clinics, said the National University Health System (NUHS) on Friday (Oct 23). In Singapore, gastric cancer is the fifth cause of cancer deaths in men and the sixth in women, claiming around 300 lives yearly. It is the third leading cause of cancer deaths worldwide, as it is often detected at the later stages, making it difficult to treat. Gastric cancer is usually diagnosed through endoscopy, a procedure perceived to be expensive and invasive, as it involves inserting a thin tube with a camera into the patient's mouth and all the way down to the stomach. An endoscopy costs around $200 to $800 with medical subsidy, according to the Ministry of Health's website. On the other hand, using the blood test would be more cost-effective - it would be priced at under $200 at public hospitals. The test is also non-invasive, and can encourage higher uptake among the public for early detection of the cancer and reduce reliance on endoscopy. It would take around three hours to run in a clinical lab and can deliver results to the patient's doctor within a week. The project to develop the new blood test began in 2012. It was led by Professor Jimmy So, head and senior consultant with the National University Hospital's (NUH) division of general surgery (upper gastrointestinal surgery); Professor Yeoh Khay Guan, senior consultant with the NUH's division of gastroenterology and hepatology; and Associate Professor Too Heng-Phon from the National University of Singapore Yong Loo Lin School of Medicine's department of biochemistry. The team also included clinicians and scientists from NUHS; the Bioprocessing Technology Institute (BTI) of the Agency for Science, Technology and Research (A*Star); national platform Diagnostics Development Hub; and MiRXES, a Singapore-headquartered molecular diagnostic company that was spun off from A*Star's BTI.  The blood test can detect 87 per cent of all gastric cancers, including 87.5 per cent of stage one cancers, by looking out for patterns of microRNA - a type of gene in the blood sample. The results were found to be more accurate compared with conventional blood tests for gastric cancer, and were highly sensitive across age groups, genders, ethnicities and tumour stages. More on this topic   Related Story Researchers work to boost treatment of gastric cancer   Related Story Study links gastric cancer to protein level Using a panel of 12 microRNA biomarkers that can differentiate gastric cancer patients from normal patients with an accuracy of more than 92 per cent, an initial test kit was manufactured in 2012. From 2013 to 2018, the test kit was validated among some 5,000 subjects from Singapore, and received approval from the Health Sciences Authority last year. Prof So said: "The majority of gastric cancer patients are diagnosed at advanced stages, for which the five-year survival rate is lower than 5 per cent. Early detecting is thus key to reducing death from gastric cancer. To bring about a meaningful fall in the gastric cancer mortality rate, an effective strategy that would detect gastric cancer early so as to enable prompt intervention is required." He added: "This non-invasive blood test is a breakthrough in gastric cancer diagnosis and it may potentially be used as an effective screening test for the early diagnosis of gastric cancer." As it costs less than endoscopy, the test could potentially be used as part of the national screening programme of gastric cancer in high-risk groups. Patients who have positive 12-microRNA test results will then be recommended to go for endoscopy. More on this topic   Related Story Singapore medical company invents non-invasive cancer screening tests; receives US$20m in funding   Related Story NUS team's 'scorecard' to detect cancer, predict patient survival Prof Too, however, emphasised that the test does not replace endoscopy, and instead provides an option to patients who may not be keen on initial endoscopic screening. Instead, it "adds to the current cancer detection tool armamentarium", and provides the public with access to better healthcare through its convenience and non-invasiveness.