FUJIFILM Medical Systems U.S.A. and Helio Health announced a collaboration to advance blood-based screening for early-stage liver cancer — combining the HelioLiver Test with Fujifilm’s 510(k)-cleared µTASWako® i30 biomarker system.
Collaboration enables acceleration of early cancer detection and surveillance.
LEXINGTON, Mass. and IRVINE, Calif., May 12, 2021 /PRNewswire/ — FUJIFILM Medical Systems U.S.A., Inc., a leading provider of biomarkers to assess the risk for the development of hepatocellular carcinoma (HCC), and Helio Health, an AI-driven healthcare company developing early cancer detection tests, today announced their collaboration to provide a blood-based assay that can help with the earlier detection of liver cancer. Through this relationship, Helio Health’s DNA methylation and biomarker-based blood test technology, recognized as the HelioLiver Test, will leverage Fujifilm’s 510(k)-cleared µTASWako® i30 immunological test system for liver cancer biomarkers.
Liver cancer is the fastest growing and second deadliest cancer worldwide. According to the American Cancer Society, liver cancer incidence rates have more than tripled since 1980, while the death rates have more than doubled during this time. Studies show that early detection of liver cancer is critical to successful outcomes with a survival rate that is 12 times higher if caught in early versus late stages. These statistics underscore the need for more advanced solutions and therapies for early liver cancer detection.
“Potential curative treatment options are more readily available when liver cancer is detected at an early stage. We believe that this collaboration will provide expanded monitoring and treatment options for patients at high risk of developing liver cancer. The Fujifilm team is looking forward to leveraging our combined resources to offer clinicians market-leading surveillance and diagnostic technologies.”
Data presented in November 2020 from the U.S. CLiMB trial, a multi-center, prospective clinical study, suggest that the HelioLiver 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 positive data provides further evidence of the HelioLiver Test’s ability to provide earlier detection with greater accuracy for liver cancer. The HelioLiver Test is under regulatory review for registration by the China National Medical Products Administration (NMPA).
“We are excited to join forces with Fujifilm in our mutual mission to simplify cancer screening with a simple blood draw. Fujifilm has a strong global presence and track record of developing and commercializing diagnostic tests. Fujifilm’s market expertise will also enable us to solidify adoption of the HelioLiver Test in the U.S. market, especially where ultrasound remains the standard of care for early liver cancer detection.”
About Fujifilm
FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of innovative diagnostic imaging products and medical informatics solutions. Its in vitro diagnostics (IVD) portfolio includes clinical lab reagents and biomarkers to assess the risk for the development of hepatocellular carcinoma in patients with chronic liver disease. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Lexington, Massachusetts. For more information, please visit fujifilmhealthcare.com.
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. 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.
SOURCE FUJIFILM Medical Systems U.S.A., Inc. View source version on PR Newswire.