Immunovia’s next-gen pancreatic cancer test shows strong performance in validation study

Pancreatic cancer test shows promise: ©Sebastian Kaulitzki - stock.adobe.com

Immunovia announced positive results from its VERIFI study, marking the second clinical validation of its next-generation pancreatic cancer diagnostic test. The study met its primary endpoint, with the test successfully identifying 77% of stage I and II pancreatic cancer cases, a crucial step in advancing early detection for one of the deadliest forms of cancer.

“The high accuracy of the Immunovia test in detecting stage I and II PDAC in a second independent clinical population of high-risk patients is very encouraging,” said Patricio Polanco, co-director of the Pancreatic Cancer Program and the Pancreatic Cancer Prevention Clinic at the Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center. “Additional biomarkers to support the diagnosis of patients with early-stage disease are critical for improving long-term oncologic outcomes in pancreatic cancer.”

Pancreatic cancer has a grim prognosis, with a five-year survival rate of just 13%. Early detection is critical to improving patient outcomes, particularly among high-risk individuals, including those with a family history of pancreatic cancer, genetic predispositions, or pancreatic cysts that may progress to malignancy.

Immunovia’s next-generation test was evaluated using 385 blood samples from six leading U.S. pancreatic cancer centers. Researchers analyzed 115 samples from patients with Stage I and II pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, against 270 control samples from high-risk individuals without cancer.

“We are excited to see additional proof of the accuracy of our next-generation test,” said Jeff Borcherding, CEO of Immunovia. “Completing a second successful clinical validation study will strengthen our efforts to secure insurance reimbursement for the test. We look forward to sharing additional data and analysis from the VERIFI study in upcoming scientific meetings and publications.”

Immunovia plans to launch its test in the third quarter of 2025, with further clinical studies slated to evaluate its performance in broader high-risk populations. The company is also engaging with regulatory bodies and potential commercial partners to accelerate market adoption.

With an estimated 1.8 million high-risk individuals in the United States alone, Immunovia aims to position its test as a key tool for early pancreatic cancer detection.