Immunovia

The peer-reviewed article, "Validation of a serum-based biomarker signature for detection of early-stage pancreatic ductal adenocarcinoma," describes results from the CLARITI study of Immunovia's PancreaSure test, demonstrating the test's ability to detect early-stage pancreatic cancer in high-risk individuals.

“I am pleased to see the scientific rigor of the CLARITI study recognized by the editors and peer reviewers of the prestigious journal Gastroenterology,” said Dr. Aimee Lucas, lead author of the CLARITI study. “The CLARITI study was a robust case-control study—the largest clinical validation to date of a blood-based pancreatic cancer test. The sensitivity and specificity achieved across 202 samples from stage 1 and 2 pancreatic cancer patients and 864 control samples from high-risk individuals without cancer demonstrate the promising diagnostic potential of the PancreaSure test.” Dr. Lucas is Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai Morningside Hospitals and one of the PRECEDE Consortium Principal Investigators working on early detection.

Dr. Diane Simeone, Director of Moores Cancer Center at UC San Diego and Founding Director of the PRECEDE Consortium, added that, “The PRECEDE Consortium is pleased to be collaborating with Immunovia as part of our common goal of finding a way to reliably detect pancreatic cancer at its earliest, most treatable stages.”

In the CLARITI study, the PancreaSure test detected 78% of stage 1 and 2 cases of pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer. The test demonstrated specificity of 94%, correctly characterizing approximately 19 of 20 non-cancerous high-risk control samples as “negative”.

"Publication in Gastroenterology provides important peer-reviewed validation of PancreaSure and confirms the rigor of the CLARITI study," said Jeff Borcherding, CEO of Immunovia. "We're grateful to our clinical collaborators and external authors who guided the study design, provided hundreds of rare blood samples, and authored a clear and compelling manuscript. We are especially appreciative of the PRECEDE Consortium, which made this research possible through its extensive network of pancreatic cancer surveillance centers."

The CLARITI study was previously selected for presentation in the “Best of DDW” session at the 2025 Digestive Disease Week conference, the world’s largest gastroenterology conference.

For more information, please contact: 
Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com 

About Gastroenterology
Gastroenterology is the most prominent journal in the field of gastrointestinal disease. As the flagship journal of the American Gastroenterological Association, Gastroenterology delivers authoritative coverage of clinical, translational, and basic studies of all aspects of the digestive system, including the liver and pancreas.

Immunovia in brief  
Immunovia AB (IMMNOV: Nasdaq Stockholm), 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
 
About the PRECEDE Consortium
The PRECEDE Consortium is an international network of more than 60 academic medical centers working together in a unique collaborative approach to increase the survival rate for pancreatic cancer through early detection. Since opening in 2020, PRECEDE Consortium sites have assembled the largest high-risk cohort of nearly 10,000 individuals with family history or genetic risk factors for pancreatic cancer, with longitudinal clinical data and biospecimen acquisition and tracking. PRECEDE is headquartered at Moores Cancer Center at UC San Diego, one of only 57 National Cancer Institute-designated Comprehensive Cancer Centers in the nation. For more information about the PRECEDE Consortium, please contact Jessica Forres at jessica@ekkopr.com.

For more information, go to www.precedestudy.org.