The blood-based test detects circulating tumor RNA to facilitate early diagnosis of hepatocellular carcinoma in high-risk patients.
Hepion Pharmaceuticals has in-licensed a novel biomarker assay from Cirna Diagnostics that detects mutant circulating tumor RNA (ctRNA) to facilitate early diagnosis of hepatocellular carcinoma (HCC) in high-risk patients with cirrhosis.
The licensing agreement advances Hepion’s strategic focus on liquid biopsy tests for early cancer detection and complements its recently acquired methylated DNA test for liver cancer, the mSEPT9 PCR-based assay. The company has also secured rights to potentially extend Cirna’s ctRNA platform for other cancer indications as the technology develops.
Most cases of liver cancer are HCC, which is the sixth most common cancer worldwide and the third deadliest globally due to its high mortality-to-incidence ratio. Current HCC surveillance methods miss up to 75% of early-stage cancers, according to Hepion.
“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,” says Kaouthar Lbiati, MD, chief executive officer at Hepion, in a release.
RNA-Based Detection Platform
The ctRNA biomarker assay is a blood-based test that reads RNA signals shed by tumors into circulation. It detects cancer-specific mutant RNA variants in blood, offering what the company calls a next-generation approach to liquid biopsy.
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 HCC-specific variants integrated into a single multiparametric blood test.
“Circulating tumor RNA liquid biopsy offers a more abundant signal and detects mutations and splicing variants that are invisible to DNA-based tests,” says Aejaz Sayeed, PhD, associate professor at the Baruch S. Blumberg Institute and chief scientific officer at Cirna Diagnostics, in a release. “Our ctRNA platform also sheds light on the ‘dark’ or regulatory genome and highlights novel noncoding elements associated with cancer.”
The ctRNA platform was co-invented by Timothy Block, PhD, a member of Hepion’s board of directors, and Sayeed.
Commercial Applications
Hepion plans to pursue Clinical Laboratory Improvement Amendments lab partnerships initially, followed by pharmaceutical companion diagnostics collaborations and co-development agreements. The pathway toward regulatory submission includes potential Food and Drug Administration approval.
The platform is disease-agnostic and has direct applications in lung, breast, pancreatic, and fusion-driven cancers, with potential utility across surveillance, treatment monitoring, prognosis, and therapy selection, according to Sayeed.
The global liquid biopsy market is currently valued at $10 billion and in the US alone is projected to reach nearly $9 billion by 2035.
“We view Hepion Pharmaceuticals, under the leadership of Dr Kaouthar Lbiati, as the ideal licensing partner to advance our innovative ctRNA liquid biopsy test,” says Louis P. Kassa III, MPA, chief executive officer of the Hepatitis B Foundation, Pennsylvania Biotechnology Center, Baruch S. Blumberg Institute, and Cirna Diagnostics, in a release.
ID 127617799 © Anton Skavronskiy | Dreamstime.com
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