mSEPT9 DNA Biomarker Test
Early Detection & Surveillance of Hepatocellular Carcinoma (HCC) in Cirrhosis
Commercialization / FDA PathwayActive
Key Facts
Indication
Early Detection & Surveillance of Hepatocellular Carcinoma (HCC) in Cirrhosis
Phase
Commercialization / FDA Pathway
Status
Active
Company
About Hepion Pharmaceuticals
Hepion Pharmaceuticals has strategically pivoted to become a pure-play diagnostic company targeting the critical unmet need in early hepatocellular carcinoma (HCC) detection. Its mission is to move from missed diagnoses to timely intervention by commercializing a clinically validated methylated SEPT9 DNA test and developing a next-generation circulating tumor RNA (ctRNA) assay. The company's strategy involves a clear dual-path roadmap: generating near-term revenue via a CLIA laboratory launch while pursuing FDA approval for broader reimbursement and adoption, supported by flexible partnership models for value creation.
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