Helio Health Announces China NMPA Acceptance of Registration Application for Helio Liver Test
Life SciencesNews
By AIT News Desk On Mar 25, 2021
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Liver cancer is the fastest growing and second deadliest cancer worldwide
In China alone, more than 400,000 liver cancer diagnoses per year and nearly 100 million people living with hepatitis B virus
Helio Health, an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, announced the China National Medical Products Administration (NMPA) has accepted the Company’s registration application for its Helio Liver Test, a cell-free DNA (cfDNA) methylation blood test for the detection of hepatocellular carcinoma (HCC) – or liver cancer.
The registration submission is based on data from Helio’s VICTORY clinical trial, a multi-center, blinded case-control study to evaluate the sensitivity, specificity and performance of the Helio Liver Test compared with current standard of care testing. The study evaluated 1,093 individuals in China with HCC and benign liver diseases as well as healthy controls. Helio plans to submit data from the study to a peer-reviewed journal for publication later this year.
Helio Health宣布中国NMPA接受Helio肝脏测试的注册申请
生命科学新闻
AIT新闻台2021年3月25日
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