Immunovia

The annual report can be downloaded in pdf format and is available on Immunovia’s website.

Important events 2025

2025 – The year Immunovia launched PancreaSure and transitioned to a commercial company.

In 2025, Immunovia achieved a major milestone by launching PancreaSure, a next-generation blood test for early detection of pancreatic cancer, in the United States. The company transitioned from a development-stage organization to a commercial enterprise, building momentum across clinical, regulatory, and commercial fronts.

Key achievements include:

• PancreaSure commercially launched in the United States, with seven high-risk surveillance centers agreeing to use the test in the first month of launch.
• Five clinical studies published in peer-reviewed scientific journals, including the pivotal CLARITI study in Gastroenterology.
• CLARITI study recognized as “Best of DDW” at the world’s largest gastroenterology conference, Digestive Disease Week.
• Medicare reimbursement rate of $897 secured for PancreaSure on the Clinical Laboratory Fee Schedule.
• College of American Pathologists (CAP) accreditation received for Immunovia’s laboratory in North Carolina, affirming rigorous quality standards.
• Twelve high-risk surveillance centers implemented PancreaSure testing by year-end, including Harvardaffiliated Beth Israel Deaconess Medical Center and NYU Perlmutter Cancer Center.
• Over SEK 140 million raised through a rights issue and warrant exercises to fund the commercial launch and clinical program.
• AFFIRM study interim analysis demonstrated 87.9% cancer detection in stage III and IV pancreatic cancer with 97.7% specificity in healthy controls.
• Licensing agreement signed with Proteomedix, securing manufacturing independence and reducing costs of goods sold.

Immunovia’s key priorities for 2026:

1. Expand commercial adoption of PancreaSure with a dedicated sales team.
2. Submit for Medicare coverage and begin billing insurance companies.
3. Secure a strategic commercialization partner to accelerate growth.

Building on the strong commercial and clinical momentum of 2025, Immunovia is positioned to drive meaningful test volume growth and take important steps toward reimbursement. With a proven, accurate test, growing physician demand, and a clear path to coverage, the future is bright for Immunovia in 2026 and beyond.

For more information, please contact:
Jeff Borcherding 
CEO and President 
jeff.borcherding@immunovia.com