Helio Health宣布中国NMPA接受Helio肝脏测试的注册申请

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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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    肝癌是全球增长最快，死亡人数第二大的癌症
    仅在中国，每年就诊断出40万例肝癌，将近1亿人患有乙型肝炎病毒

由AI驱动的医疗保健公司Helio Health致力于通过简单的抽血使早期癌症检测测试商业化，该公司宣布中国国家药品监督管理局（NMPA）接受了该公司的Helio Liver Test的注册申请.Helio Liver Test是一种无细胞DNA（ cfDNA）甲基化血液测试，用于检测肝细胞癌（HCC）–或肝癌。

提交的注册信息基于Helio的VICTORY临床试验数据，该试验是一项多中心，无盲病例对照研究，旨在评估Helio肝试验与当前护理标准相比的敏感性，特异性和性能。该研究评估了中国1,093例肝癌和良性肝病患者以及健康对照者。 Helio计划将这项研究的数据提交给同行评审的期刊，以在今年晚些时候出版。

https://aithority.com/technology ... r-helio-liver-test/