
Hepion Pharmaceuticals, New Day Diagnostics execute binding letter of intent
The LOI covers in-licensing of diagnostic tests for celiac disease, respiratory multiplex, helicobacter pylori (H. pylori), and hepatocellular carcinoma.
Hepion Pharmaceuticals Inc., a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis, hepatocellular carcinoma, and other chronic liver diseases, has announced that it has entered into a binding letter of intent (LOI) with Knoxville-headquartered New Day Diagnostics LLC to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori), and hepatocellular carcinoma (HCC). The celiac, respiratory multiplex, and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time.
The diagnostic tests covered under the LOI represent a combined addressable market exceeding $15 billion. The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a $5.6 billion market, growing at 6.6 percent annually through 2029, by enabling efficient, simultaneous detection of COVID-19, Influenza A/B, and RSV from a single sample. The H. pylori CE-IVD targets the $700 million market for early, non-invasive detection of infections that can lead to gastric ulcers and cancer, with 6.0 percent projected growth through 2032. CeliaCare CE-IVD supports rapid screening for celiac disease—an underdiagnosed autoimmune condition—in a $457 million market growing at 10.4 percent annually through 2034. The mSEPT9 assay, when used in early detection of hepatocellular carcinoma (HCC) in high-risk patients, serves an $8.7 billion market projected to grow 6.7 percent annually through 2030. Collectively, these diagnostics offer clinical utility across multiple conditions while opening access to meaningful commercial opportunities in global markets.
“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,” said John Brancaccio, Executive Chairman and Interim Chief Executive Officer (CEO) of Hepion.
“This alliance represents a strategic step forward in our mission to bring accessible, high-impact diagnostics to patients around the world,” said Eric Mayer, CEO of New Day Diagnostics. “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.”
Like what you've read?
Forward to a friend!