Blood-Based Test Outperforms Ultrasound in Early Liver Cancer Detection

Patients with liver cirrhosis and chronic hepatitis B are at a higher risk for developing hepatocellular carcinoma (HCC), the most prevalent type of liver cancer. The American Association for the Study of Liver Diseases (AASLD) recommends these high-risk patients undergo surveillance every six months. Regular testing is crucial for early cancer detection, which significantly increases the likelihood of successful treatment. Common causes of cirrhosis, a leading risk factor for HCC, include Hepatitis B, Hepatitis C, excessive alcohol consumption, obesity, diabetes, and nonalcoholic fatty liver disease (NAFLD). Although ultrasound is the standard method for liver surveillance, it is often considered insufficient by many physicians due to performance issues and patient accessibility barriers. Now, a reliable and accessible approach using a simple blood draw has been validated in a clinical trial with promising results.

The HelioLiver Dx test, developed by Helio Genomics (Irvine, CA, USA) and powered by artificial intelligence (AI), analyzes cell-free DNA (cfDNA) methylation patterns, serum protein biomarkers, and patient demographic data to detect HCC in cirrhotic patients who require biannual surveillance as per AASLD guidelines. Helio’s innovative algorithm identifies specific methylation patterns indicative of cancer and searches for proteins typically elevated in HCC cases. The CLiMB study, which included 1,968 subjects at high risk for liver cancer, represents the largest completed prospective, multi-center clinical trial for a liver cancer detection liquid biopsy in the United States. The study primarily aimed to compare the sensitivity and specificity of the HelioLiver Dx test with that of ultrasound in detecting HCC among patients predisposed to the disease due to liver cirrhosis.

Participants in the study were diagnosed with liver cirrhosis through various methods including blood analytes, ultrasound, elastography, diagnostic imaging via CT or MRI (as indicated in radiology reports), or liver biopsy (as indicated in pathology reports). They were deemed eligible for HCC surveillance by their physicians. The results from the CLiMB study revealed that the HelioLiver Dx test not only demonstrated greater sensitivity than ultrasound in detecting overall HCC lesions but also showed better performance in identifying early-stage and small lesions across a diverse patient group with liver cirrhosis. The HelioLiver Dx test achieved the prespecified coprimary endpoints, showing superior sensitivity and non-inferior specificity compared to ultrasound in the detection of HCC lesions. Additionally, it met a secondary endpoint by exhibiting superior sensitivity in detecting HCC lesions up to 4 cm in diameter. Overall, the HelioLiver Dx test outperformed ultrasound in terms of sensitivity in detecting HCC lesions among cirrhotic patients.

"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,” added 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.”

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