Helio Health Announces Publication of ENCORE Data in Hepatology Communications, Demonstrating Superior Performance of HelioLiver for Early Detection of Liver Cancer

IRVINE, Calif., March 7, 2022 /PRNewswire/ -- Helio Health ("Helio"), an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, today announced that Hepatology Communications published positive results from the ENCORE study validating HelioLiver's strong clinical performance in detecting the presence of early hepatocellular carcinoma (HCC), the most common form of liver cancer and the seventh most common cancer worldwide but the second in cancer-related mortality, often due to late diagnosis.¹ In this prospective, blinded, multi-center Phase 2 study, HelioLiver demonstrated high specificity (91%) and high sensitivity (76%) in detecting early-stage (stage I and II) HCC, significantly outperforming other clinically available detection tools such as AFP (57%), GALAD (65%), and ultrasound (47%).^2,3 When considering HCC overall, HelioLiver performed at an 85% sensitivity with the same 91% specificity.²

HCC Diagnostic Tests	Early Stage (I + II) Sensitivity	Overall Sensitivity
HelioLiver2	76%	85%
AFP (≥ 20 ng/mL)2	57%	62%
GALAD Score (≥ -0.63)2	65%	75%
Ultrasound3	47%	84%
Note: Table denotes HelioLiver sensitivities at 91% specificity2
2 Lin N, et al. 2021.
3 Tzartzeva K, et al. 2018.

Helio developed its next-generation sequencing platform, ECLIPSE^TM, to identify 77 methylation targets across 28 genes. These DNA markers work in combination with the serum HCC proteins AFP, AFP-L3%, and DCP to enhance the multi-analyte algorithm.

• The area under receiver operating characteristic (AUROC) for HelioLiver was 0.944, demonstrating significantly better predictive ability than other tests.
• At a fixed specificity of 87.5%, HelioLiver achieved 87% sensitivity for early-stage HCC and 90% sensitivity overall.
• 10 of the 28 genes used in the HelioLiver test were found to be directly involved in molecular pathways known to be implicated in HCC pathogenesis while only one of the investigated but unselected 497 genes met the same criteria, suggesting that the markers in HelioLiver are more biologically relevant than tests that utilize these other genes.

Hepatology Communications is the official open-access, peer-reviewed journal of the American Association for the Study of Liver Diseases (AASLD), dedicated to the fast dissemination of high-quality research in hepatology. AASLD is the most respected medical guidelines organization for liver disease in the United States.

"We are very pleased with these trial results. The high-risk population for liver cancer is in great need of a more effective and less operator-dependent test to improve patient outcomes," said Dr. Mindie Nguyen, board-certified hepatologist at Stanford University Medical Center and co-author on the paper. "Blood-based tests can be more accessible and convenient, as they can be done in the same visit as a consultation and in the same blood draw for other routine care, leading to higher adherence rates."

"Acceptance of our study results into this top, peer-reviewed journal represents external validation of the significant value HelioLiver brings to patients who are at high risk for liver cancer," said Justin Chen Li, Chief Executive Officer, Helio Health. "The ENCORE study builds on years of research completed by our team and collaborators, who can now take great pride that their work is driving patient outcomes in the clinic."

"Helio Health is one of the first pioneers to use cfDNA methylation for cancer detection," said Dr. David Taggart, Chief Scientific Officer, Helio Health. "These findings from ENCORE clearly demonstrate the value of the ECLIPSE platform for capturing informative methylation signals from cfDNA, as well as Helio's superior bioinformatics capabilities in making sense of those signals. We look forward to leveraging this platform to advance our pipeline into other disease areas such as colon, lung and breast cancer."

HelioLiver is undergoing further evaluation as part of Helio's pivotal, prospective biomarker study, CLiMB (NCT03694600), where the performance of the test will be directly compared to ultrasound using multi-phasic MRI as the standard of care for HCC diagnosis.

About ENCORE
The ENCORE study (NCT05059665) was a blinded, multicenter validation study using blood specimens drawn from 247 participants, including 122 participants diagnosed with HCC and 125 control participants diagnosed with a benign liver 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 (HCC), the most common form of liver cancer. 

"This recognition of Helio's ENCORE study further validates the performance of HelioLiver in the early detection of liver cancer," said Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics. "We hope to continue improving the standard of care for patients at high risk for hepatocellular carcinoma by growing the availability of HelioLiver."

Fulgent Genetics (NASDAQ: FLGT) is the exclusive commercial partner to Helio Health for the distribution of HelioLiver, which is currently available for order as a laboratory developed test in the United States and Canada.    

Healthcare 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 Helio ECLIPSE NGS Platform
Helio's proprietary ECLIPSE™ platform analyzes cfDNA by using a targeted next-generation sequencing (NGS) approach to identify DNA methylation patterns that are associated with specific cancers. DNA methylation plays a key role in many biological processes and aberrant DNA methylation often occurs very early during cancer progression.

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.

Media
Melissa Roy
ICR Westwicke
Melissa.Roy@westwicke.com
(203) 682-8285

¹ Fitzmaurice C, Abate D, Abbasi N, et al. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2017. JAMA Oncol. 2019;5(12):1749-1769. doi:10.1001/jamaoncol.2019.2996
² Lin N, Lin Y, Xu J, et al. A multi-analyte blood test for accurate and early detection of hepatocellular carcinoma. Poster presented at: American Association for the Study of Liver Diseases – The Liver Meeting; November 12-15, 2021; Virtual.
³ 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. doi:10.1053/j.gastro.2018.01.064

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SOURCE Helio Health