3/3/2026, 5:38:19 AM
MORRISTOWN, N.J. — March 3, 2026 — Leads & Copy — Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) has in-licensed a novel biomarker assay from Cirna Diagnostics LLC that detects mutant circulating tumor RNA (ctRNA) to facilitate early diagnosis of hepatocellular carcinoma (HCC) in high-risk patients with cirrhosis.
The agreement, driven by CEO Kaouthar Lbiati, MD, advances Hepion’s strategy and complements its recently acquired methylated DNA test for early liver cancer detection, the mSEPT9 PCR-based assay.
Hepion’s strategic focus is advancing clinically proven liquid biopsy tests to aid in early HCC diagnosis and surveillance, and potentially for other solid tumor types. The company has also secured rights to potentially extend Cirna’s ctRNA platform for other indications as the technology matures. The ctRNA license for HCC and extension rights augment Hepion’s growing pipeline as the company prepares its mSEPT9 PCR-based assay for commercialization.
The company believes both assays will fulfill a major unmet need, as current HCC surveillance methods miss up to 75% of early-stage cancers. Most liver cancer cases (75-90%) are HCC, the sixth most common cancer worldwide and the third deadliest cancer globally.
According to Dr. Lbiati, Hepion’s diagnostic tests are designed to catch tumors early in high-risk patients and minimize later-stage diagnoses. She said the pathway toward regulatory submission and commercialization of the ctRNA platform will present opportunities for CLIA lab partnerships initially, pharma companion diagnostics collaborations in the midterm, and co-development/co-commercialization agreements through the platform’s lifecycle. The company believes these opportunities will enhance the value of its ctRNA asset and the broader portfolio of biomarkers, benefiting patients and shareholders.
Louis P. Kassa III, MPA, CEO of the Hepatitis B Foundation, the Pennsylvania Biotechnology Center (PABC), the Baruch S. Blumberg Institute (BSBI) – which created the assay – and Cirna Diagnostics, said Hepion Pharmaceuticals, under the leadership of Dr. Kaouthar Lbiati, is the ideal licensing partner to advance their innovative ctRNA liquid biopsy test.
The ctRNA biomarker assay is a blood-based test that reads the RNA signals shed by tumors into circulation, detecting cancer-specific mutant RNA variants. Unlike DNA-based approaches, ctRNA captures actively expressed tumor signatures, providing earlier detection and improved specificity across surveillance and early detection use cases. The platform has been validated for HCC across independent cohorts, with standardized RNA extraction and a repertoire of HCC-specific variants integrated into a single multiparametric blood test.
The ctRNA platform was co-invented by Timothy Block, PhD, a member of Hepion’s Board of Directors and co-founder of the Hepatitis B Foundation, Baruch S. Blumberg Institute (BSBI), and Pennsylvania Biotechnology Center, and Aejaz Sayeed, PhD, associate professor at the BSBI and chief scientific officer at Cirna Diagnostics.
Dr. Sayeed explained that circulating tumor RNA liquid biopsy offers a more abundant signal and detects mutations and splicing variants that are invisible to DNA-based tests. He added that the ctRNA platform sheds light on the ‘dark’ or regulatory genome and highlights novel noncoding elements associated with cancer, offering a confidence-boosting tool for clinicians seeking diagnostic clarity for their at-risk patients. According to Sayeed, the platform is disease-agnostic, with 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.
With its ctRNA and mSEPT9 diagnostic assays, Hepion is taking steps toward a theranostics-enabling approach that presents a commercial opportunity. The global liquid biopsy market is currently valued at $10 billion and is projected to reach nearly $9 billion in the U.S. alone by 2035.
Hepion Pharmaceuticals (OTCQB: HEPA) is pioneering early cancer detection solutions with advanced liquid biopsy diagnostics. Leveraging deep expertise in liver biology, Hepion acquired platforms for precise diagnosis of early hepatocellular carcinoma (HCC) in people with cirrhosis – a clinically validated methylated DNA (SEPT9) biomarker test for near-term commercialization, and a circulating tumor RNA (ctRNA) biomarker assay with potential application across solid tumors. With a roadmap from Clinical Laboratory Improvement Amendments (CLIA) launch to U.S. Food and Drug Administration (FDA) approval and multiple partnership pathways, Hepion aims to transform how solid tumors are detected and monitored in high-risk patients.
Source: Hepion Pharmaceuticals, Inc.
