Hepion Pharmaceuticals In-Licenses Novel ctRNA Biomarker Assay for Early Hepatocellular Carcinoma Detection
核心洞察
Hepion Pharmaceuticals has in-licensed a novel circulating tumor RNA (搜索) (ctRNA (搜索)) biomarker assay from Cirna Diagnostics (搜索) to facilitate early diagnosis of hepatocellular carcinoma (搜索) in high-risk patients with cirrhosis (搜索).
The next-generation liquid biopsy platform detects cancer-specific mutant RNA variants in blood and offers improved specificity compared to DNA-based approaches, with potential applications across multiple solid tumor types.
Current HCC surveillance methods miss up to 75% of early-stage cancers, representing a significant unmet medical need that this technology aims to address.
Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) announced on March 3, 2026, that it has in-licensed a novel biomarker assay from Cirna Diagnostics (搜索) LLC that detects mutant circulating tumor RNA (搜索) (ctRNA (搜索)) to facilitate early diagnosis of hepatocellular carcinoma (搜索) (HCC) in high-risk patients with cirrhosis (搜索). The licensing deal represents a strategic evolution for the precision diagnostics company under the leadership of Chief Executive Officer Kaouthar Lbiati, MD.
Addressing Critical Unmet Medical Need
HCC represents 75-90% of all liver cancer (搜索) cases and stands as the sixth most common cancer worldwide, with a high mortality-to-incidence ratio that makes it the third deadliest cancer globally. Current HCC surveillance methods miss up to 75% of early-stage cancers, highlighting a significant gap in diagnostic capabilities that the new ctRNA (搜索) platform aims to address.
"Our diagnostic tests are designed to catch tumors early in high-risk patients and minimize later-stage diagnoses where prognosis is grim, thereby significantly improving the probability of survival in high-risk patients," said Dr. Lbiati.
Next-Generation Liquid Biopsy Technology
The ctRNA (搜索) biomarker assay is a blood-based test that reads RNA signals shed by tumors into circulation. Unlike DNA-based approaches, ctRNA captures actively expressed tumor signatures, providing earlier detection and improved specificity across both surveillance and early detection use cases. The platform has been validated for HCC across several independent cohorts, with standardized RNA extraction and a repertoire of HCC-specific variants integrated into a single multiparametric blood test.
"Circulating tumor RNA (搜索) liquid biopsy offers a more abundant signal and detects mutations and splicing variants that are invisible to DNA-based tests," explained Aejaz Sayeed, PhD, associate professor at the Baruch S. Blumberg Institute (搜索) and chief scientific officer at Cirna Diagnostics (搜索). "Our ctRNA (搜索) platform also sheds light on the 'dark' or regulatory genome and highlights novel noncoding elements associated with cancer."
Broad Clinical Applications
The ctRNA (搜索) platform was co-invented by Timothy Block, PhD, a member of Hepion's Board of Directors and co-founder of the Hepatitis B Foundation (搜索), Baruch S. Blumberg Institute (搜索), and Pennsylvania Biotechnology Center (搜索), along with Dr. Sayeed. The technology demonstrates disease-agnostic potential with direct applications in lung, breast, pancreatic, and fusion-driven cancers, and potential utility across the full spectrum of clinical management, including surveillance, treatment monitoring, prognosis, and therapy selection.
Hepion has secured rights to potentially extend Cirna's ctRNA (搜索) platform for other indications as the technology matures, complementing its recently acquired methylated DNA test for early detection of liver cancer (搜索), the mSEPT9 (搜索) PCR-based assay.
Strategic Commercialization Pathway
"Our pathway toward regulatory submission and commercialization of the ctRNA (搜索) platform will present numerous opportunities for CLIA lab partnerships initially, pharma companion diagnostics collaborations in the midterm, and co-development/co-commercialization agreements through the platform's lifecycle," Dr. Lbiati noted.
Louis P. Kassa III, MPA, Chief Executive Officer of the Hepatitis B Foundation (搜索), the Pennsylvania Biotechnology Center (搜索), the Baruch S. Blumberg Institute (搜索), and Cirna Diagnostics (搜索), commented: "As with many cancers, early detection of hepatocellular carcinoma (搜索) is key to improving patient outcomes, and there is a clear need for non-invasive biomarkers that detect HCC. We view Hepion Pharmaceuticals, under the leadership of Dr. Kaouthar Lbiati, as the ideal licensing partner to advance our innovative ctRNA (搜索) liquid biopsy test."
Market Opportunity
With its ctRNA (搜索) and mSEPT9 (搜索) diagnostic assays, Hepion positions itself within the expanding liquid biopsy market, which is currently valued at $10 billion globally and growing. In the U.S. alone, the market is projected to reach nearly $9 billion by 2035, presenting substantial commercial opportunities for the company's theranostics-enabling approach.
The company maintains a clear roadmap from Clinical Laboratory Improvement Amendments (CLIA) launch to U.S. Food and Drug Administration (FDA) approval, with multiple partnership pathways designed to transform how solid tumors are detected and monitored in high-risk patients.