LUND, Sweden - Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, today announced that the Centers for Medicare & Medicaid Services (CMS) has finalized a national payment rate of $897 for the PancreaSure test. Effective January 1st, 2026, this represents the second of three steps on the path to Medicare reimbursement.
The Clinical Laboratory Fee Schedule (CLFS) establishes the payment rate that Medicare will pay for a laboratory test once coverage is in place. This finalized rate of $897 follows the preliminary determination announced by Immunovia in September.
"The finalized rate is an important milestone in our reimbursment strategy," said Jeff Borcherding, CEO of Immunovia. "The rate of $897 fairly recognizes the substantial clinical and economic value of the PancreaSure test in detecting pancreatic cancer early. This rate determination supports our ongoing engagement with payers and is an important step in enabling us to begin billing insurance providers in 2026."
Determination of the CLFS rate is the second of three steps to securing Medicare reimbursement. The first step was obtaining a code that identifies the PancreaSure test when Immunovia submits claims to insurers. The code for PancreaSure (0599U) became effective October 1, 2025.
Now that the CLFS rate has been finalized, the final step to securing Medicare reimbursement is to obtain a Local Coverage Determination (LCD), which is a decision that the PancreaSure test is reasonable and medically necessary. To obtain an LCD, Immunovia will next submit an extensive package of clinical data that demonstrates proof of the following attributes:
• Analytical validity: The laboratory accurately measures the individual biomarkers in the test.
• Clinical validity: The test correctly identifies what is pancreatic cancer and what is not
• Clinical utility: The test impacts physician decision making and improves patient outcomes
A regional Medicare Administrative Contractor (MAC) will review this evidence, seek public input, and make a coverage determination. Immunovia has successfully generated extensive data showing the analytical validity and clinical validity of the PancreaSure test. The Company is currently building the clinical utility evidence necessary to support an LCD request submission, which the company is targeting for 2026.
For further information, please contact
Jeff Borcherding, CEO
jeff.borcherding@immunovia.com
Immunovia in brief
Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer. Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
USA is the world's largest market for detection of pancreatic cancer. The Company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm.
For more information, please visit www.immunovia.com.