Helio Genomics announced acceptance of an oral presentation at the European Association for the Study of the Liver (EASL) Congress, which takes place June 5-8, 2024 in Milan, Italy.
Dr. Richard Van Etten, Helios Chief Medical Advisor, will present data from the Company’s pivotal Clinical Trial Multi-analyte Blood Test (CLiMB) study on Saturday, June 8 at 3:15 PM CET.
CLiMB is a multi-site, prospective study comparing the sensitivity and specificity of Helios HelioLiver multi-analyte blood test 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 ClinicalTrials.gov.
HelioLiver evaluates cell free DNA (cfDNA) methylation patterns, serum protein markers, and demographic information for the detection of HCC, and patients at high risk for HCC (namely those with liver cirrhosis and chronic hepatitis B) are recommended for surveillance every six months by the American Association for the Study of Liver Diseases (AASLD).
The CLiMB study enrolled 1,968 subjects at high-risk for liver cancer, making it the largest completed prospective, multi-center clinical trial for a liver cancer detection liquid biopsy test conducted in the United States. Subjects were diagnosed with liver cirrhosis by blood analytes (APRI = 1.5 or Bonacini cirrhosis discriminant score = 8 or Lok index > 0.5), ultrasound and elastrography (> 12.5 kPa), diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report) or liver biopsy (liver cirrhosis indicated on pathology report), and those who were eligible for HCC surveillance as determined by the subjects physician.
