Immunovia, a leading firm in pancreatic cancer diagnostics, has announced the triumphant completion of its CLARITI study, short for Clinical Validation of Next-Generation Test for Early-Stage Pancreatic Cancer, aimed at identifying early-stage pancreatic ductal adenocarcinoma (PDAC).
The study, which analyzed over a thousand patient specimens, met its primary aim by surpassing the set accuracy benchmarks, signifying a significant achievement in Immunovia’s quest to enhance patient survival through the early detection of pancreatic malignancies.
Highlights of the Study Include:
- Remarkable Precision:
The innovative test displayed a sensitivity of 78% and a specificity of 94% for detecting stage 1 and 2 PDAC. Among patients aged 65 and above, sensitivity reached 80% with specificity at 91%. -
Exceeds CA19-9:
Compared to CA19-9, an FDA-certified biomarker for pancreatic cancer surveillance, Immunovia’s test was 14 percentage points more sensitive (p < 0.001) while maintaining similar specificity. -
Potential for Early Diagnosis:
The next-gen test proved equally effective in identifying both stage 1 and stage 2 pancreatic tumors, supporting its capability as an efficient early detection tool. -
Enhanced Results with Newer Samples:
Performance improved in samples collected within the past five years, with sensitivity at 82% and specificity reaching 95%. The study involved handling 56% of pancreatic cancer samples older than 5 years due to the scarcity of stage 1 and 2 samples. It’s anticipated that fresh samples used clinically will exhibit even higher accuracy.
Conducted with blood samples sourced from 18 renowned pancreatic cancer institutions globally, the CLARITI study stands as the most extensive clinical validation research for a blood-based pancreatic cancer test within a high-risk group. From the 1,066 samples assessed, 202 derived from stage 1 and 2 pancreatic cancer patients, and 864 served as controls, originating from high-risk individuals primarily identified by family history or genetic predisposition.
Dr. Rosalie Sears, a key study investigator, affirmed, “This trial affirms the Immunovia test’s high precision in detecting early-stage pancreatic cancer among high-risk populations. The increased accuracy observed from recently collected samples is promising, indicating potentially superior results with clinical application on fresh samples.”
Jeff Borcherding, Immunovia’s CEO and president, remarked, “This milestone represents a sea change in pancreatic cancer diagnostics. Our next-generation test demonstrates the precision essential for early detection needs. We extend our deepest appreciation to the network of pancreatic cancer experts and clinicians who played a role in this extensive and demanding study. These convincing results pave Immunovia’s path as a formidable leader in the early-detection arena, pushing us closer to realizing our mission of improving survival rates globally.”
With today’s positive results, Immunovia is set to launch its advanced test in the US market by the latter half of 2025. Concurrently, additional clinical studies will take place through 2025 to evaluate the test’s accuracy, clinical benefits, and economic advantages across diverse high-risk patient segments, supporting further regulatory and reimbursement efforts.
Immunovia AB is committed to revolutionizing pancreatic cancer survival rates via the development of accessible, blood-based tests that detect proteins and antibodies signifying high-risk individuals may have developed pancreatic cancer.