Collaboration enables acceleration of early cancer detection and surveillance


FUJIFILM Medical Systems U.S.A. and Helio Health collaborate to advance blood-based screening methods for early-stage liver cancer. (Credit: Belova59 from Pixabay)

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,” said Henry Izawa, Vice President, Modality Solutions and Clinical Affairs, FUJIFILM Medical Systems U.S.A., Inc. “The Fujifilm team is looking forward to leveraging our combined resources to offer market leading technologies that 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 from the clinical trial provides further evidence of the HelioLiver 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. 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,” added Kenneth Chahine, Ph.D., J.D., Chief Executive Officer of Helio Health.

Source: Company Press Release