New ENCORE data presented at The Liver Meeting® 2021: at 91% specificity, HelioLiver showed 76% sensitivity in early-stage HCC and 85% overall — outperforming AFP and the GALAD model.
Data from the ENCORE study to be presented at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD).
IRVINE, Calif. and TEMPLE CITY, Calif., Nov. 8, 2021 /PRNewswire/ — Helio Health (“Helio”) and its commercial partner, Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent”), today announced new data at AASLD demonstrating the performance of HelioLiver in detecting early hepatocellular carcinoma (HCC). At 91% specificity, the sensitivity of HelioLiver was 76% in early-stage HCC and 85% in overall HCC,1 demonstrating superior performance over alpha fetoprotein (AFP) alone and the GALAD model.
| Early Stage (I + II) Sensitivity | Overall Sensitivity | |
|---|---|---|
| HelioLiver1 | 76% | 85% |
| AFP (≥ 20 ng/mL)1 | 57% | 62% |
| GALAD Score (≥ -0.63)1 | 65% | 75% |
| Ultrasound2 | 47% | 84% |
Note: Table denotes HelioLiver sensitivities at 91% specificity.1
HelioLiver is a multi-analyte blood test that utilizes both cell-free DNA (cfDNA) methylation patterns and protein tumor markers to detect early-stage HCC with high accuracy. HelioLiver has the potential to reduce morbidity and mortality in HCC patients as there are more curative treatment options when the cancer is found at earlier stages. A highly sensitive blood test can drive patient adherence to surveillance guidelines and provide a more convenient and cost-effective way to detect HCC.
“As one of the fastest growing and deadliest cancers worldwide, it is essential to detect liver cancer as early as possible to initiate treatment intervention to optimize successful patient outcomes. These results indicate HelioLiver has significant promise to redefine the standard of care in terms of providing a highly sensitive, easy-to-use blood test for patients and healthcare providers alike.”
“As a result of rigorous scientific evaluations, these new findings underscore HelioLiver’s potential to detect liver cancer early and ultimately save lives. Through our partnership with Fulgent Genetics, we look forward to delivering new early cancer diagnostic technologies beginning with HelioLiver in the U.S. in the near future.”
The ENCORE study was a blinded, multicenter validation study using blood specimens drawn from 303 subjects. The study included 122 subjects diagnosed with HCC, 125 control subjects diagnosed with a benign liver disease, and 56 subjects diagnosed with other cancer types.
The poster presentation, titled “A Multi-Analyte Blood Test for Accurate and Early Detection of Hepatocellular Carcinoma,” will be available for viewing by the attendees of The Liver Meeting® beginning November 8, 2021. The HelioLiver test continues to be evaluated in Helio’s pivotal prospective study, CLiMB (NCT03694600). For more information about HelioLiver, please visit www.helioliver.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.
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 the Helio Health and Fulgent Genetics Partnership
In a strategic partnership announced in August of 2021, Helio Health and Fulgent Genetics plan to commercialize and co-brand 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, and 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.
1. 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.
2. 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.
SOURCE Helio Health and Fulgent Genetics, Inc. View source version on PR Newswire.