Insight

Immunovia Announced Major Milestone in Early-Stage Pancreatic Cancer Detection

Photo taken from cancercenter.com

Dec 11, 2024, 14:59

Immunovia Announced Major Milestone in Early-Stage Pancreatic Cancer Detection

Immunovia, a leading company in pancreatic cancer diagnostics, has announced a major milestone in the development of its next-generation test for detecting early-stage pancreatic cancer.

Immunovia

The company successfully completed the CLARITI study, a large-scale clinical trial aimed at validating the accuracy of its blood test for pancreatic ductal adenocarcinoma (PDAC), one of the deadliest forms of cancer.

The study, which involved over 1,000 patient samples from 18 of the world’s top pancreatic cancer centers, has shown exceptionally strong results, exceeding the predefined accuracy criteria set by Immunovia.

The next-generation test demonstrated an impressive 78% sensitivity and 94% specificity for detecting stage 1 and stage 2 PDAC, which are the earliest and most treatable stages of the disease. The test performed particularly well in patients aged 65 and older, with a 80% sensitivity and 91% specificity, offering significant promise for earlier detection in older, high-risk populations.

Moreover, the test outperformed CA19-9, the FDA-approved biomarker currently used to monitor pancreatic cancer, showing a 14 percentage point increase in sensitivity (p<0.001) while maintaining equivalent specificity.

Another key finding from the study is that the test demonstrated improved accuracy when using blood samples collected in the past five years, with a 82% sensitivity and 95% specificity.

This suggests that, in real-world clinical use, where fresh blood samples would be tested, the accuracy of the test could be even higher.

The CLARITI study is regarded as the largest reported clinical validation for a pancreatic cancer blood test in a high-risk population.

It included 202 samples from patients with stage 1 and stage 2 PDAC, and 864 control samples from individuals at high risk for pancreatic cancer, mostly due to family history or genetic predisposition.

This rigorous study design, using high-risk controls, makes the CLARITI trial a more challenging and realistic assessment of the test’s performance compared to studies that use healthy controls.

Jeff Borcherding, CEO and President of Immunovia, added,

“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, and these results position Immunovia as a leader in the early-detection market. We are deeply grateful to the pancreatic cancer experts and clinical leaders who partnered with us on this large, rigorous study.”

Milestone

With these promising results, Immunovia is on track to introduce its next-generation test to the U.S. market in the second half of 2025.

The company will also conduct further clinical studies throughout 2025 to assess the test’s accuracy, clinical impact, and economic value across various high-risk patient groups.

These studies will play a key role in supporting regulatory submissions and efforts to secure reimbursement, ultimately bringing the test one step closer to being a critical tool in the fight against pancreatic cancer.