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FUJIFILM Medical Systems U.S.A., Inc. and Helio Health Collaborate to Advance Blood-based Screening Methods for Early-Stage Liver Cancer

Collaboration enables acceleration of early cancer detection and surveillance

May 12, 2021

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Lexington, Mass. and Irvine, Calif., – 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.

About Fujifilm

FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of innovative diagnostic imaging products and medical informatics solutions that meet and exceed the evolving needs of healthcare facilities today and into the future. It’s ever expanding medical imaging solutions span digital radiography (DR), detectors, portables and suites, mammography systems with digital breast tomosynthesis, computed tomography solutions for oncology and radiology applications, technologically advanced flexible and surgical endoscopy and fluoroscopy solutions. Fujifilm enables interoperability through its Systems Integration offering as well as its comprehensive, AI-supported Synapse® Enterprise Imaging portfolio, which includes the TeraMedica Division of Fujifilm. Fujifilm’s 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 www.fujifilmhealthcare.com.

FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $22.1 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.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.

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.