IRVINE, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Helio Genomics (“Helio” or “the Company”), an AI-driven healthcare company specializing in diagnostics technology and test development for cancer detection, showcased the results from their latest clinical trial on Saturday, 8th June at the 2024 European Association for the Study of the Liver (EASL) Congress in Milan, Italy. Dr. Richard Van Etten, Helio’s Chief Medical Advisor, presented data from the Company’s pivotal 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.”
CLiMB is a multi-site, prospective study comparing the sensitivity and specificity of Helio’s 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 ClinicalTrials.gov. 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.
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).
“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,” said Dr. Richard A. 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.”
"The results from our CLiMB study clearly demonstrate the superior performance of our HelioLiver Dx test compared to ultrasound,” said Justin Chen Li, Chief Executive Officer, Helio Genomics. “We are thrilled with the potential of our blood-based test to detect liver cancer early leading to better patient outcomes and ultimately saving more lives.”
"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,” said Justin Chen Li, Chief Executive Officer, 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.”
Data Highlights:
- HelioLiver Dx is a multi-analyte blood-based test employing a proprietary algorithm that utilizes a wide array of biomarkers such as cell-free DNA (cfDNA) methylation, serum proteins and patient demographic information to accurately detect HCC in cirrhotic patients.
- 1,968 adult patients with cirrhosis were enrolled across the U.S., of which 1,556 participants made up the validation cohort, with 1,268 evaluable patients.
- 46 participants (3.6%) had HCC, confirmed by MRI:
- 80% lesions ≤ 4 cm
- 46% lesions < 2cm
- 59% T1 stage lesions according to the TNM staging system
- 46 participants (3.6%) had HCC, confirmed by MRI:
- The HelioLiver Dx test met the prespecified coprimary endpoints – Overall superior sensitivity (> 5%) and non-inferior specificity (> -10%) compared to ultrasound for detecting HCC lesions.
- The HelioLiver Dx test met the prespecified secondary endpoint – Superior sensitivity compared to ultrasound for detecting HCC lesions ≤ 4 cm in diameter.
- HelioLiver Dx outperformed ultrasound for sensitivity to detect HCC lesions in cirrhotic patients:
- All HCC lesions: 47.8% for HelioLiver Dx vs. 28.3% for ultrasound
- HCC lesions ≤ 4 cm: 37.8% for HelioLiver Dx vs. 13.5% for ultrasound
- HCC lesions < 2 cm: 28.6% for HelioLiver Dx vs. 0% for ultrasound. Notably, ultrasound failed to detect any lesions < 2 cm in the CLiMB study.
- T1 HCC lesions: 44.4% for HelioLiver Dx vs. 11.1% for ultrasound
About the CLiMB Trial
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. The primary goals of the study were to evaluate the sensitivity and specificity of HelioLiver Dx 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 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 subject’s physician.
About Helio Genomics
Helio Genomics is a commercial stage, AI-driven healthcare company specializing in diagnostics technology and test development for cancer detection. 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
