Helio Health and Fulgent Genetics launched HelioLiver™, a multi-analyte blood test for the early detection of hepatocellular carcinoma (HCC) — detecting liver cancer at its earliest stages from a simple blood draw.
HelioLiver can detect liver cancer in the earliest stages with a simple, non-invasive blood draw. HelioLiver is now available for patients through a provider order.
IRVINE & TEMPLE CITY, Calif., December 06, 2021 (BUSINESS WIRE) — Helio Health (“Helio”) and its commercial partner, Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent”), today announced the commercial launch of HelioLiver™, a multi-analyte blood test that incorporates cell free DNA (cfDNA) methylation patterns and serum protein markers for the detection of hepatocellular carcinoma (HCC) – the most common form of liver cancer. HelioLiver can detect HCC at its earliest stages when lesions are still very small, an area where traditional standard-of-care imaging tools often fall short, with the potential to enable more curative treatment options known to increase five-year survival rates by up to 13 times compared to when cancer has metastasized.1,2
Recent data presented at The Liver Meeting® 2021 outlined HelioLiver’s superior sensitivity over currently available blood-based tests. With a specificity of 91%, HelioLiver demonstrated 76% sensitivity in detecting early-stage HCC, significantly outperforming other detection tools such as AFP (57%), GALAD (65%), and ultrasound (47%).3,4
“We are excited to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most. We are proud to partner with Fulgent to launch this innovative, simple, and reliable test that has the potential to redefine the future of cancer testing and foster better patient outcomes.”
HelioLiver offers a simplified process for patients with a blood draw that can be conducted during a routine check-up, providing a quick and accurate way to receive regular surveillance for people at risk of developing liver cancer. While the American Association for the Study of Liver Diseases (AASLD) guidelines recommend ultrasound screening every six months for patients who are at risk, studies have shown that as few as 20% of patients actually receive regular surveillance due to the inconvenience of accessing testing via ultrasound.5 Helio believes this number can dramatically increase with this new, blood-based test.
“Through our partnership with Helio, our joint priority is to bring HelioLiver to providers and patients in a seamless manner. Leveraging our extensive commercial infrastructure, we are well-positioned to deliver an easy ordering experience for providers with our representatives at the ready to provide the best-in-class white glove service throughout the entire experience.”
Providers can place orders online at HelioLiver.com/how-to-order, via phone (+1 626-350-0537) or email at info@helioliver.com to get connected with a representative. For more information about HelioLiver and its clinical performance, please visit www.HelioLiver.com.
About Fulgent Genetics
Fulgent Genetics is a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health. Fulgent’s proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy, and competitive turnaround times.
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.
About the Helio Health and Fulgent Genetics Partnership
In August 2021, Helio Health and Fulgent Genetics entered into a strategic partnership to co-brand and commercialize HelioLiver, a cell-free DNA (cfDNA) methylation blood test that incorporates protein markers and demographics for the detection of hepatocellular carcinoma (HCC). Fulgent is responsible for laboratory operations, supply chain operations, marketing and sales, initially focused in the U.S. and Canada. Helio provides intellectual property and continued support across research and development, publication development, market access and sales, as well as reimbursement operations. Fulgent and Helio will also collaborate on the development of additional liquid biopsy tests for different types of cancer in the future.
The original press release contained forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please refer to the source release for the full forward-looking statements and associated risk factors.
1. Yu NC, Chaudhari V, Raman SS, et al. CT and MRI improve detection of hepatocellular carcinoma, compared with ultrasound alone, in patients with cirrhosis. Clin Gastroenterol Hepatol. 2011;9(2):161-167.
2. National Cancer Institute: Cancer Stat Facts – Liver and Intrahepatic Bile Duct Cancer. seer.cancer.gov/statfacts/html/livibd.html [accessed November 30, 2021].
3. Lin N, Lin Y, Xu J, et al. A multi-analyte blood test for accurate and early detection of hepatocellular carcinoma. Poster presented at: AASLD – The Liver Meeting; November 12–15, 2021; Virtual.
4. Tzartzeva K, Obi J, Rich NE, et al. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018;154(6):1706-1718.e1.
5. Wang C, Chen V, Vu V, et al. Poor adherence and low persistency rates for hepatocellular carcinoma surveillance in patients with chronic hepatitis B. Medicine (Baltimore). 2016;95(35):e4744.
SOURCE Helio Health; Fulgent Genetics. View source version on Business Wire.