New data demonstrate high accuracy of blood-based cfDNA methylation test for the detection of HCC
Test has potential to outperform current screening modalities for early stage HCC within high risk populations
IRVINE, Calif., Nov. 13, 2020 /PRNewswire/ — Helio Health, an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, today presented new data that demonstrate the high accuracy and screening value of its cell-free DNA (cfDNA) methylation blood test for the detection of hepatocellular carcinoma (HCC), the fifth most common and second deadliest cancer worldwide.¹ The data were presented in an electronic poster session at the The Liver Meeting® 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place virtually November 13-16, 2020.
Data from this study suggest that the Helio Liver Test, a multi-analyte HCC-specific blood test, provides greater sensitivity and specificity for the detection of early-stage HCC and disease surveillance in high-risk communities compared to current screening modalities.
The Helio Liver Test, together with protein markers and demographics, was validated in an independent cohort of 631 subjects, including patients with HCC (n=291) and age-matched healthy controls (n=340), compared to serum alpha-fetoprotein (AFP) alone, a well-known marker for liver cancer. Results showed that the Helio Liver Test produced 88.7% (95% CI: 87.3-90.0%) sensitivity in early-stage (stages 1 and 2) HCC, while sensitivity for AFP alone was 57.5% (95% CI: 52.6-61.8%). Ultrasound, the current standard of care for early-stage HCC detection, has approximately 47% (95% CI: 33-61%) sensitivity.
“Patients with HCC suffer from high mortality, often associated with poor rates of early detection. There is a significant unmet need to advance standard surveillance methods for this disease and also improve adherence to screenings and subsequent surveillance for those at high risk of HCC,” said Robert Gish, M.D., Clinical Professor of Medicine at Loma Linda University Medical Center, University of Nevada Las Vegas, University of Nevada Reno, and Medical Director of the Hepatitis B Foundation.
“Liver cancer is one of the fastest growing and deadliest cancers worldwide and early detection is critical to successful outcomes, especially among high-risk populations. These positive data provide further evidence of the Helio Liver Test’s ability to provide earlier detection with greater accuracy for liver cancer and enable groundbreaking advances in the detection and management of this growing disease,” said Kenneth Chahine, Ph.D., J.D., Chief Executive Officer of Helio Health. “We look forward to advancing development of this important and easy to use test as we work to make it available to patients and healthcare providers who currently have limited options for accurate and sensitive early-stage detection.”
About Helio Health
Helio Health is an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw. The company’s mission is to simplify cancer screening so lives can be saved by detecting cancer earlier. With Helio’s AI-driven technology, both physicians and their patients gain powerful insights from accurate, accessible, and convenient blood tests.
Building on a robust research and development program, and with access to thousands of patient samples, the company is currently in clinical trials in the US and China with its lead liver cancer detection test. Helio’s development program is focused on liver, colon, breast and lung cancer.
Helio Health is headquartered in Irvine, CA, with R&D, GMP and CLIA facilities in Irvine, CA and West Lafayette, IN, Guangzhou and Beijing.
¹Mount Sinai. What is Hepatocellular Carcinoma (HCC)? Accessed November 5, 2020. https://www.mountsinai.org/care/cancer/services/liver/hepatocellular-carcinoma.
SOURCE Helio Health