Helio Health and Fulgent Genetics Announce Late-Breaking Positive Performance Data of HelioLiver for Early Liver Cancer Detection

Data from the ENCORE study to be presented at The Liver Meeting 2021, hosted by the American Association for the Study of Liver Diseases 

Helio Health and its commercial partner, Fulgent Genetics, Inc, announced new data at AASLD demonstrating the performance of HelioLiver in detecting early hepatocellular carcinoma . At 91% specificity, the sensitivity of HelioLiver was 76% in early-stage HCC and 85% in overall HCC, demonstrating superior performance over alpha fetoprotein alone and the GALAD model.

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HelioLiver is a multi-analyte blood test that utilizes both cell-free DNA (cfDNA) methylation patterns and protein tumor markers to detect early-stage HCC with high accuracy. HelioLiver has the potential to reduce morbidity and mortality in HCC patients as there are more curative treatment options when the cancer is found at earlier stages. A highly sensitive blood test can drive patient adherence to surveillance guidelines and provide a more convenient and cost-effective way to detect HCC.

“As one of the fastest growing and deadliest cancers worldwide, it is essential to detect liver cancer as early as possible to initiate treatment intervention to optimize successful patient outcomes,” said Dr. Richard A. Van Etten, Director of the NCI-designated Chao Family Comprehensive Cancer Center and member of the Division of Hematology/Oncology at the University of California, Irvine. “These results indicate HelioLiver has significant promise to redefine the standard of care in terms of providing a highly sensitive, easy-to-use blood test for patients and healthcare providers alike.”

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“As a result of rigorous scientific evaluations, these new findings underscore HelioLiver’s potential to detect liver cancer early and ultimately save lives,” said Justin Chen Li, U.S. Chief Executive Officer, Helio Health. “Through our partnership with Fulgent Genetics, we look forward to delivering new early cancer diagnostic technologies beginning with HelioLiver in the U.S. in the near future.”

The ENCORE study was a blinded, multicenter validation study using blood specimens drawn from 303 subjects. The study included 122 subjects diagnosed with HCC, 125 control subjects diagnosed with a benign liver disease, and 56 subjects diagnosed with other cancer types.

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