Immunovia (STO:IMMNOV) has announced the completion of its CLARITI study, demonstrating positive outcomes and strong accuracy in the clinical validation of its next-generation test for the early detection of pancreatic ductal adenocarcinoma cancer (PDAC).
The company reports that the CLARITI study utilized blood samples from 18 of the world’s leading pancreatic cancer centers, marking the largest reported clinical validation study of a pancreatic cancer blood test in a high-risk patient population.
“This study validates the high accuracy of the Immunovia test in detecting stage 1 and 2 pancreatic cancer in a challenging high-risk population. The increase in accuracy for samples collected more recently is very encouraging, suggesting we could expect even better accuracy when the test is used clinically on fresh blood samples,” said Dr. Rosalie Sears, professor of molecular and medical genetics and co-director Brenden-Colson Center for Pancreatic Care at Oregon Health and Science University and an investigator on the study.
Jeff Borcherding, CEO and President of Immunovia, stated, “This marks a pivotal milestone for Immunovia in our quest to transform the pancreatic cancer landscape. Our next-generation test clearly has the accuracy to address the critical need for early detection. We are deeply grateful to the pancreatic cancer experts and clinical leaders who partnered with us on this large, rigorous, and challenging study. These compelling results position Immunovia as a leader in the early-detection market and bring us closer to fulfilling our mission of improving pancreatic cancer survival worldwide.”
With these results, Immunovia remains on track to introduce its next-generation test to the U.S. market in the second half of 2025.
