IRVINE, Calif., March 24, 2021 /PRNewswire/ — Helio Health, an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, today 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.