Data from a recent clinical study presented at the ACMG Annual Clinical Genetics Conference, held March 22– 26, 2022 by the American College of Medical Genetics and Genomics, highlighted the performance of the HelioLiver Test. The results were published in Hepatology Communications.[1]

HelioLiver* is a revolutionary new test that offers at-risk patients an easy way to screen for liver cancer. It is a multi-analyte blood test that incorporates cell-free DNA (cfDNA) methylation patterns, clinical variables, serum protein markers, and demographic information for the (early) detection of hepatocellular carcinoma (HCC), the most common form of liver cancer.

Liver cancer
As the principal histologic type of liver cancer, HCC accounts for the great majority of liver cancer diagnoses and deaths. The incidence rate of HCC is rising, and it is one of the most common cancers worldwide and accounts for substantial morbidity and mortality. [2] Most patients with HCC are diagnosed at a late stage, highlighting the need for more accurate surveillance tests.

At the ACMG Annual Clinical Genetics conference, Dhruvajyoti Roy, Ph.D., Director of Technology/Medical Science Affairs, Helio Health, presented the data from the ENCORE study (NCT05059665) validating HelioLiver’s strong clinical performance for early detection of HCC. In this perspective, blinded, multi-center 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%). [1][3] The HelioLiver test also showed a superior overall sensitivity (85%) for the detection of all-stage HCC at the same 91% specificity.[1]

“The efficacy of HCC surveillance to increase early detection and improve survival has been affirmed by several studies; and a more sensitive and non-invasive multi-analyte blood-based test could help catch the disease earlier, which may lead to better outcomes,” Roy noted.

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Dhruvajyoti Roy, Ph.D., Director of Technology/Medical Science Affairs, Helio Health, Inc. presented the clinical data at the ACMG Annual Clinical Genetics Meeting 2022. Photo courtesy: © 2022 Helio Health. Used with permission.

A simplified process
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. 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.

* Fulgent Genetics is the exclusive commercial partner to Helio Health for the distribution of HelioLiver, which is currently available for patients through a provider order. For more information about HelioLiver and its clinical performance, please visit the HelioLiver website.

Clinical trials
Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC (ENCORE) – NCT05059665
Clinical Trial Multi-analyte Blood Test (CLiMB) – NCT03694600

[1] Lin N, Lin Y, Xu J, Liu D, Li D, Meng H, et al. A multi-analyte cell-free DNA–based blood test for early detection of hepatocellular carcinoma. Hepatol Commun. 2022;00:1–11.
[2] McGlynn KA, Petrick JL, El-Serag HB. Epidemiology of Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1(Suppl 1):4-13. doi: 10.1002/hep.31288
[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

Feature image: Exhibition hall. Photo courtesy: © 2022 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Conference. Used with permission.

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