Immunovia AB (IMMNOV: Nasdaq Stockholm), a pancreatic cancer diagnostics company, today announced that it has received regulatory approval for its PancreaSure test in California, US, enabling commercial sales in the state. The approval represents an important milestone in Immunovia's three-phase commercial launch strategy, under which the company will initially focus on leading medical centers operating surveillance programs for patients at elevated risk of developing pancreatic cancer.
In October 2025, Immunovia applied for regulatory approval to offer the test for commercial use in California. By meeting the requirements of both federal CLIA (Clinical Laboratory Improvement Amendments) standards and California's additional state-specific laboratory regulations, including stricter requirements for laboratory operations and oversight, PancreaSure was approved. The approval allows Immunovia to legally accept, analyze, and report diagnostic test results from California-based healthcare providers.
"The regulatory approval is welcome news to the medical community and high-risk individuals in California. PancreaSure is a test with demonstrated accuracy, and its availability allows us to strengthen our surveillance program for pancreatic cancer. The test may enable earlier diagnosis of pancreatic cancer." comments Dr. Walter Park, Professor and Medical Director of the Pancreas Clinic at Stanford Hospitals and Clinics.
California is a large and strategically important regional market for the PancreaSure test in the US, as numerous leading academic medical centers and high-risk surveillance programs are active in the state. The recent approval allows Immunovia to offer PancreaSure directly to clinics, creating new opportunities to scale up the use of the test.
"We're pleased with the approval of PancreaSure in California, as it allows us to offer the test directly to leading clinicians and top-tier medical centers in the state. We have already received interest from multiple clinics in California that are eager to implement PancreaSure in their high-risk surveillance programs and we will now act quickly to ensure that the test becomes available at select surveillance centers in accordance with our stepwise commercial strategy," says Jeff Borcherding, CEO and President, Immunovia.
PancreaSure is a blood-based test for the early detection of pancreatic cancer in high-risk individuals. The test is clinically validated and designed to support surveillance programs by identifying disease at earlier, more treatable stages.
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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.
