Pancreatic cancer diagnostics company Immunovia AB (STO:IMMNOV) announced on Tuesday that it will launch its PancreaSure test in the United States on 2 September 2025.
The launch follows more than two years of development and clinical validation.
Immunovia's initial strategy centres on building advocacy among key opinion leaders and the 200 high-risk pancreatic cancer surveillance programmes across the US. Physicians will order the test through an online portal, with samples processed at Immunovia's North Carolina laboratory. Results will be delivered directly to physicians via the portal.
Later, Immunovia will aim to team up with a strategic commercial partner to expand reach and drive adoption among other practitioners and specialists, while building volume among existing users. The partners will then increase testing volume within all target groups and secure payer coverage to drive revenue.
PancreaSure will first be offered as a patient-pay service at USD995, with a discounted prompt-pay price of USD750. A financial assistance programme will also be available, reducing costs to as little as USD0, USD100, or USD200 depending on patient need.
Insurance billing for the PancreaSure test is expected to begin in 2026.
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
InSysBio agrees new collaborative project with BeOne Medicines
Physiomics secures new modelling contract with Numab Therapeutics
Mabwell reports first patient dosed with 7MW4911 in US trial
Atossa Therapeutics' founder and CEO named one of The Top 50 Healthcare Technology CEOs of 2025
Avacta secures FDA clearance for second pre|CISION oncology programme
Guardant Health and Merck enter multi-year oncology diagnostics collaboration
Akeso secures NMPA review acceptance for gumokimab in ankylosing spondylitis