Summary: Helio Genomics‘ clinical trial results show that their HelioLiver Dx test outperforms ultrasound in detecting hepatocellular carcinoma (HCC) in patients with liver cirrhosis.

Key Takeaways:

  1. The HelioLiver Dx test demonstrated higher sensitivity than ultrasound, particularly in detecting early-stage and small HCC lesions.
  2. By offering a convenient and accurate blood-based test, HelioLiver Dx has the potential to improve early detection and increase adherence to testing, reducing HCC morbidity and mortality.
  3. The test combines cell-free DNA methylation patterns, serum protein biomarkers, and patient demographic information, providing superior detection in a diverse patient cohort.

Helio Genomics, an AI-driven healthcare company specializing in diagnostics technology and test development for cancer detection, released results from their latest clinical trial demonstrating the superior performance of their HelioLiver Dx test compared to ultrasound. 

Richard Van Etten, MD, PhD, Helios Chief Medical Advisor, presented data from the company’s clinical trial (CLiMB) study, entitled “A prospective, blinded, multicenter U.S. evaluation of a multi-analyte blood-based test for the detection of hepatocellular carcinoma (HCC) in patients with cirrhosis.”

“Data from the CLiMB study demonstrate that the HelioLiver Dx test is not only more sensitive than ultrasound at detecting HCC lesions overall but also detects more early stage and small lesions in a diverse cohort of patients with liver cirrhosis,” says Van Etten, director of the NCI-designated Chao Family Comprehensive Cancer Center and member of the Division of Hematology/Oncology at the University of California, Irvine. “HelioLiver Dx has significant promise to redefine the standard of care with a convenient, and accurate, blood-based test, through both improved early detection as well as increase in testing adherence, thereby reducing HCC morbidity and mortality.”

About the CLiMB Study

CLiMB is a multi-site, prospective study comparing the sensitivity and specificity of Helios multi-analyte blood-based test, HelioLiver Dx, to ultrasound for detection of hepatocellular carcinoma (HCC) within a population at high risk of HCC due to liver cirrhosis. Details of the study can be found on The CLiMB trial was designed to be a fully prospective, all-comer study to measure the true sensitivity of ultrasound in early-stage HCC by performing a contemporaneous MRI on all subjects. Many existing published studies are case-controlled or did not include contemporaneous MRI, over-stating the performance of ultrasound.

Hepatocellular Carcinoma in Patients with Liver Cirrhosis

The HelioLiver Dx test, developed by Helio Genomics and powered by AI, utilizes cell-free DNA (cfDNA) methylation patterns along with serum protein biomarkers and patient demographic information to detect HCC in patients with liver cirrhosis, who are recommended to be surveilled every six months by the American Association for the Study of Liver Diseases (AASLD).

Further reading: Liver Cancer Screening Rates Doubled With Mailed Orders

“The results from our CLiMB study clearly demonstrate that the HelioLiver Dx test passed endpoints and demonstrated superior sensitivity and non-inferior specificity compared to ultrasound in a real world setting,” says Justin Chen Li, CEO, Helio Genomics. “We believe our blood-based test can address many barriers to care and socioeconomic inequities that exist today, leading to better patient outcomes and ultimately saving more lives.”

 Featured image: Doctor holding a HelioLiver test kit. Photo: Helio Genomics