Hepion Enters Global Diagnostics Market With In-License Of High-Growth CE-IVD Test Portfolio

Hepion Pharmaceuticals has announced a strategic pivot with the signing of a binding letter of intent (LOI) to in-license a portfolio of diagnostic tests from New Day Diagnostics LLC. The licensed products include CE-marked tests for celiac disease, a respiratory multiplex panel (COVID-19, Influenza A/B, and RSV), Helicobacter pylori (H. pylori), and hepatocellular carcinoma (HCC). While Hepion had previously focused on therapeutics for liver diseases such as NASH and HCC, this move signals a shift toward diagnostics with immediate commercialisation potential in Europe.

John Brancaccio, Executive Chairman and Interim Chief Executive Officer of Hepion expressed his enthusiasm, saying, “The CE marked tests provide Hepion with the ability to generate near term revenues in European Union countries by leveraging the existing distributor network relationships that New Day Diagnostics has established. We are excited by this opportunity and look forward to working with New Day to maximize value.”

The four diagnostic tests collectively address a global market exceeding $15 billion. The respiratory multiplex panel, using RT-PCR for simultaneous pathogen detection, targets a $5.6 billion market with 6.6% annual growth. The H. pylori test enables early, non-invasive detection of a common gastric infection in a $700 million market. CeliaCare, a test for celiac disease, addresses a $457 million market with a strong 10.4% CAGR, reflecting rising awareness and diagnosis rates. The mSEPT9 assay for early HCC detection targets the largest opportunity an $8.7 billion market projected to grow 6.7% annually through 2030.

“This alliance represents a strategic step forward in our mission to bring accessible, high-impact diagnostics to patients around the world. We’re excited to partner with Hepion to expand the reach of these CE-marked tests, bring them to the United States, and unlock new opportunities to improve early detection and outcomes across multiple disease areas,” said Eric Mayer, CEO of New Day Diagnostics. 

With European market access already granted via CE marking, the company is positioned to commercialise these products in the near term while potentially exploring U.S. regulatory pathways. This step helps the company to open new revenue streams, which are a significant shift to a new phase in the company’s development process.