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Positive Results in Early Detection of Liver Cancer

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Helio Health, 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 TestsEarly Stage (I + II) SensitivityOverall Sensitivity
HelioLiver276%85%
AFP (≥ 20 ng/mL)257%62%
GALAD Score (≥ -0.63)265%75%
Ultrasound347%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, ECLIPSETM, 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.

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.

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editor

Editor in chief for eTurboNew is Linda Hohnholz. She is based in the eTN HQ in Honolulu, Hawaii.

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