Hepion In-Licenses ctRNA Liquid Biopsy Assay To Strengthen Early Hepatocellular Carcinoma Detection Strategy

Hepion Pharmaceuticals, Inc. announced it has in-licensed a novel circulating tumor RNA (ctRNA) biomarker assay from Cirna Diagnostics LLC to support the early detection of hepatocellular carcinoma (HCC) in high-risk patients, particularly those with cirrhosis. HCC accounts for approximately 75–90% of liver cancer cases and remains one of the most lethal cancers globally due to its high mortality-to-incidence ratio.

Under the leadership of CEO Kaouthar Lbiati, MD, this agreement marks another step in Hepion’s strategic shift toward precision diagnostics. The ctRNA assay complements the company’s recently acquired methylated DNA-based mSEPT9 PCR assay for early liver cancer detection. Hepion is now focused on advancing clinically validated liquid biopsy tools for early diagnosis and surveillance of HCC and potentially other solid tumors. In addition to licensing the HCC assay, the company has secured rights to expand the ctRNA platform into other indications as the technology evolves.

“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, Hepion CEO. “Our pathway toward regulatory submission and commercialization of the ctRNA 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. We believe these opportunities will enhance the value of our ctRNA asset and the broader portfolio of biomarkers, benefiting both patients and shareholders.”

The ctRNA test is a blood-based liquid biopsy that detects cancer-specific mutant RNA variants shed into circulation by tumors. Unlike DNA-based methods, ctRNA analysis captures actively expressed tumor signals, potentially enabling earlier detection and greater specificity in both screening and surveillance settings. The platform has been validated for HCC across multiple independent cohorts, integrating standardized RNA extraction techniques and a panel of HCC-specific variants into a multiparametric assay. Hepion believes these diagnostic tools address a significant unmet need, as current HCC surveillance strategies may miss up to 75% of early-stage cancers.

“Circulating tumor RNA liquid biopsy offers a more abundant signal and detects mutations and splicing variants that are invisible to DNA-based tests,” explained Dr. Sayeed. “Our ctRNA platform also sheds light on the ‘dark’ or regulatory genome and highlights novel noncoding elements associated with cancer. It is a confidence-boosting tool for clinicians seeking diagnostic clarity for their at-risk patients. The platform is also disease-agnostic; it has direct applications in lung, breast, pancreatic, and fusion-driven cancers, and potential utility across the full arc of clinical management, encompassing surveillance, treatment monitoring, prognosis, and therapy selection.”

The ctRNA technology was co-invented by Timothy Block, PhD, co-founder of the Hepatitis B Foundation, Baruch S. Blumberg Institute, and Pennsylvania Biotechnology Centre, along with Aejaz Sayeed, PhD, associate professor at the Blumberg Institute and chief scientific officer at Cirna Diagnostics.

“As with many cancers, early detection of hepatocellular carcinoma is key to improving patient outcomes, and there is a clear need for non-invasive biomarkers that detect HCC,” commented Louis P. Kassa III, MPA, Chief Executive Officer of the Hepatitis B Foundation, the Pennsylvania Biotechnology Center (PABC), the Baruch S. Blumberg Institute (BSBI) – which created the assay – and Cirna Diagnostics. “We view Hepion Pharmaceuticals, under the leadership of Dr. Kaouthar Lbiati, as the ideal licensing partner to advance our innovative ctRNA liquid biopsy test.”

With both ctRNA and mSEPT9 assays in development, Hepion aims to advance a theranostics-driven strategy in oncology diagnostics. The global liquid biopsy market is currently valued at approximately $10 billion and continues to expand, with the U.S. market alone projected to approach $9 billion by 2035.