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BioSpace: Helio to Showcase CLiMB Pivotal Trial Data at EASL 2024

Press Release May 6, 2024 5 min read Helio Genomics
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Helio’s Chief Medical Advisor, Dr. Richard Van Etten, will present late-breaking data from the pivotal CLiMB study at the EASL Congress 2024 in Milan, Italy on June 8.

IRVINE, Calif., May 06, 2024 (GLOBE NEWSWIRE) — Helio Genomics (“Helio” or “the Company”), an AI-powered precision cancer detection company, today announced acceptance of a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress, which takes place June 5–8, 2024 in Milan, Italy. EASL is the largest professional body in Europe devoted to liver health. Dr. Richard Van Etten, Helio’s 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 Helio’s 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).

About the CLiMB Trial

The CLiMB study enrolled 1,968 subjects at high-risk for liver cancer, making it the largest completed prospective, multicenter clinical trial for a liver cancer detection liquid biopsy test conducted in the United States. The primary goals of the study were to evaluate the sensitivity and specificity of HelioLiver compared to ultrasound for the detection of HCC within a population at high risk of HCC due to liver cirrhosis. 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 elastography (> 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 subject’s physician.

About Helio Genomics

Helio Genomics is a commercial-stage, AI-powered precision cancer detection company advancing early cancer detection and minimal residual disease monitoring. HelioLiver is a multi-analyte blood test that evaluates cell free DNA (cfDNA) methylation patterns, serum protein markers, and demographic information for the detection of hepatocellular carcinoma (HCC). For more information, please visit us at www.heliogenomics.com.

Investor Contact

Jeremy Feffer
Managing Director, LifeSci Advisors
jfeffer@lifesciadvisors.com

Read the Press Release

View source version on biospace.com.

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