The American Medical Association issued a new Category I CPT® Proprietary Laboratory Analyses code for HelioLiver™, establishing a reimbursement pathway for broader access to the blood test for early detection of hepatocellular carcinoma (HCC).
The approval of a CPT code establishes a reimbursement pathway for increased access to HelioLiver, a simple blood test to detect hepatocellular carcinoma (HCC) – the primary form of liver cancer.
IRVINE, Calif. and TEMPLE CITY, Calif., July 5, 2022 /PRNewswire/ — Helio Genomics (“Helio”), and its commercial partner, Fulgent Genetics (NASDAQ: FLGT) (“Fulgent”), announced that the American Medical Association (AMA) has issued a new Category I Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses code for HelioLiver™, enabling a reimbursement pathway for potential increased access and broader adoption of innovative surveillance tests for liver cancer in the U.S. The code will become effective on October 1, 2022.
HelioLiver, launched in December 2021, is 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. The provision of a CPT PLA code and expected subsequent Medicare reimbursement facilitates the seamless integration of HelioLiver into the American healthcare system, validating Helio’s values-based approach to early liver cancer detection for at-risk patients and elevating the standard of care.
“Receiving a CPT PLA code for HelioLiver marks an important step towards our vision to enable widespread, affordable access of life-saving tools for at-risk populations who need clear and convenient answers about their health. Our unique approach to AI-powered genomic insights for the early detection of cancer is now further substantiated as a critical tool for healthcare professionals with greater reimbursement potential. Access and affordability are key pillars to patient adherence to liver cancer surveillance, and Helio will continue to partner with agencies and professionals to ensure our test is meeting their standards as well as the needs of patients. We look forward to leading the charge in redefining the future of cancer through helping to identify more treatable and preventable liver cancer cases.”
The CPT PLA code for HelioLiver will allow providers to efficiently conduct routine surveillance of at-risk patients and streamline the reporting of services, claims processing and development of guidelines for medical care review, ultimately advancing more sophisticated and comprehensive care for patients.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common form of liver cancer. According to the American Cancer Society, liver cancer is the fastest growing cancer with more than 800,000 people diagnosed each year worldwide. Liver cancer is also a leading cause of cancer deaths globally, accounting for more than 700,000 deaths each year, many due to late-stage diagnosis. Detecting cancer early can be a key factor to enabling potentially curative treatment options and, as such, regular surveillance is recommended for the approximately 500 million people worldwide who are at-risk due to cirrhosis or hepatitis B.
Other conditions that are associated with HCC development are: hepatitis C, excessive alcohol use, nonalcoholic fatty liver disease (NAFLD), and inherited diseases such as hereditary hemochromatosis, primary biliary cholangitis (PBC), and Wilson’s disease.
About HelioLiver
HelioLiver is a multi-analyte blood test that incorporates cell-free DNA (cfDNA) methylation patterns, serum protein markers, and demographic information for the detection of hepatocellular carcinoma.
Based on results from the ENCORE Phase 2 prospective, blinded, multi-center study, HelioLiver demonstrated high specificity (91%) and high sensitivity (76%) in detecting early-stage (I and II) HCC, significantly outperforming other clinically available detection tools such as AFP (57%) and GALAD (65%). Ultrasound, as standard of care, showed only 47% sensitivity for early-stage HCC.1 When considering HCC at all stages, HelioLiver performed at an 85% sensitivity with the same 91% specificity.1 By detecting HCC in earlier stages, HelioLiver allows patients access to more curative options and improves outcomes overall.
Fulgent Genetics (NASDAQ: FLGT) is the exclusive commercial partner to Helio Genomics for the distribution of HelioLiver, which is currently available for order as a laboratory developed test in the United States and Canada. Providers can place orders online at helioliver.com/provider/how-to-order, via phone (+1 626-350-0537) or email at info@helioliver.com to get connected with a representative.
About Helio Genomics
Helio Genomics 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 Genomics is headquartered in Irvine, CA, with R&D, GMP and CLIA facilities in Irvine, CA and West Lafayette, IN.
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 Genetics’ 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.
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.
Media: Melissa Roy, ICR Westwicke, Melissa.Roy@westwicke.com, (203) 682-8285. Fulgent Genetics Investor Relations: Nicole Borsje, The Blueshirt Group, nicole@blueshirtgroup.com.
1. Lin N, Lin Y, Xu J, et al. A multi-analyte cell-free DNA–based blood test for early detection of hepatocellular carcinoma. Hepatol Commun. 2022;00:1–11. doi:10.1002/hep4.1918.
SOURCE Helio Genomics; Fulgent Genetics. View source version on PR Newswire.