Immunovia

The results are based on pooled data from Immunovia’s previously reported CLARITI and VERIFI validation studies, which included individuals at high risk of pancreatic ductal adenocarcinoma (PDAC) due to a genetic mutation (PGV) and/or a family history of pancreatic cancer. The current analysis was restricted to symptomatic individuals, including those with pancreatic cysts, diabetes, pancreatic abnormalities, pancreatitis, unexplained weight loss and other signs of pancreatic cancer.

PancreaSure detected Stage I and II PDAC with 83.3% sensitivity and 91.6% specificity in the high-risk symptomatic study population, consistent with the test’s performance in high-risk asymptomatic individuals in previous validations. Performance was consistent across symptomatic sub-groups and in individuals over 65 years of age – the population covered by Medicare insurance.

“The medical community seeks diagnostic tools for surveillance that perform consistently across the high-risk patient population they meet daily: symptomatic and asymptomatic, older and younger. This data is encouraging based on the findings of several validation studies with different patient subgroups. This kind of consistency supports its use in ongoing surveillance programs” comments Randall Brand, MD, professor of medicine at the University of Pittsburgh School of Medicine and director of the UPMC GI Malignancy Early Detection, Diagnosis and Prevention Program.

Because Medicare generally requires the presence of signs and/or symptoms to cover diagnostic testing, the high-risk symptomatic cohort represents the intended-use population for Immunovia’s planned submission to Medicare for a Local Coverage Determination (LCD) for PancreaSure.

"We are delighted to share these new and strong performance data for PancreaSure, which will support our upcoming application for Medicare coverage. By showing consistent performance across non-symptomatic and symptomatic individuals, these results provide further evidence of PancreaSure's potential to improve patient survival by enabling earlier detection of pancreatic cancer in the high-risk surveillance populations on which we are focused," says Jeff Borcherding, CEO and President, Immunovia.

For more information, please contact:
Jeff Borcherding
CEO and President
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.