A new blood test demonstrated higher sensitivity for detecting early-stage liver cancer compared to standard imaging in a large clinical trial.
Helio Genomics announced the publication of a study in the Journal of Hepatology demonstrating that its HelioLiver blood test is more sensitive than ultrasound for the early detection of hepatocellular carcinoma (HCC). The results come from the CLiMB clinical trial, which evaluated the performance of the multi-analyte test in patients with cirrhosis.
The CLiMB study is a prospective, multicenter, blinded US clinical trial that enrolled 1,968 patients with cirrhosis across 42 clinical sites. For the validation cohort of 1,556 patients, researchers compared HelioLiver—which combines cell-free DNA methylation patterns, serum protein markers, and demographic information—to standard abdominal ultrasound. The study used contemporaneous multiphasic magnetic resonance imaging (MRI) as the gold standard for clinical truth.
The HelioLiver test met co-primary endpoints for superior sensitivity and non-inferior specificity compared to ultrasound. For all stages of HCC, the test showed 76.1% sensitivity compared to 44.4% for ultrasound. In early-stage disease, defined as Barcelona Clinic Liver Cancer (BCLC) stages 0 and A, the test reached 71.9% sensitivity versus 36.8% for ultrasound. For very early-stage disease (BCLC 0), the test maintained 61.5% sensitivity compared to 30.8% for imaging.
“This landmark CLiMB study publication validates Helio Genomics’ leadership in delivering transformative, blood-based early detection that turns deadly surveillance gaps into lifesaving opportunities for patients with cirrhosis,” says Bharat Tewarie, CEO of Helio Genomics, in a release.
The test also met a secondary endpoint for superior sensitivity in detecting small HCC lesions measuring 4 cm or less in diameter. While ultrasound specificity was higher at 93.9% compared to 87.6% for HelioLiver, the blood test showed higher sensitivity than the combination of ultrasound plus alpha-fetoprotein (AFP) at 47.8% versus 34.8%.
Mindie H Nguyen, professor of medicine at Stanford University School of Medicine and lead principal investigator for the CLiMB trial, notes that the group fueling the rise in HCC cases includes patients with obesity, metabolic dysfunction-associated steatotic liver disease, and metabolic dysfunction-associated steatohepatitis.
“The CLiMB study underscores the limitations of current ultrasound-based surveillance and the promise of this multi-analyte test in detecting HCC at earlier, more treatable stages in patients with cirrhosis,” says Nguyen in a release.
Liver cancer is among the fastest-rising causes of cancer-related deaths in the US, with mortality doubling since 1980. While the five-year survival rate reaches 70% when the disease is identified early, only about 9% of patients with cirrhosis receive the recommended semiannual ultrasound surveillance. Barriers to imaging include scheduling difficulties, transportation issues, and limited access to specialized facilities.
“Current imaging surveillance catches less than one-third of HCC cases and misses nearly all small, early-stage tumors,” says Richard Van Etten, director of the Chao Family Comprehensive Cancer Center at the University of California, Irvine, and chief medical advisor at Helio Genomics, in a release. “This multi-analyte test offers a convenient blood-based option to help close critical gaps in early detection.”
The HelioLiver test is currently commercially available nationwide.
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