Immunovia presents data from model development study at meeting of the PRECEDE pancreatic cancer research consortium

Rhea-AI Summary

Immunovia will present updates on its next-generation pancreatic cancer detection test at the annual PRECEDE Consortium meeting. The test showed 85% sensitivity and 98% specificity in a model-development study of 623 patient samples. The PRECEDE Consortium, comprising 51 pancreatic centers worldwide, aims to increase five-year survival rates to 50% through early detection research. The consortium has enrolled over 7,000 of its targeted 10,000 high-risk patients. Immunovia plans to complete clinical validation in December 2024 and launch the test in 2025.

Positive

• Strong test performance metrics with 85% sensitivity and 98% specificity
• Collaboration with major research consortium (51 centers) strengthening clinical validation
• Clear timeline for product launch in 2025

Negative

• Product launch not expected until late 2025
• Clinical validation study still pending completion

Insights

Medical Research Analyst

The presentation of Immunovia's next-generation pancreatic cancer detection test shows promising clinical results with 85% sensitivity and 98% specificity from a substantial sample size of 623 patients. These metrics are particularly impressive for early-stage (1 and 2) pancreatic cancer detection, where early diagnosis is important for survival outcomes.

The collaboration with PRECEDE Consortium, encompassing 51 pancreatic centers and over 7,000 enrolled patients, provides robust validation opportunities and access to valuable blood samples for clinical studies. The planned commercial launch in 2025, following the completion of clinical validation in December 2024, represents a significant milestone in addressing the unmet need for early pancreatic cancer detection in the 1.8 million high-risk individuals in the US market alone.

SAN DIEGO, Nov. 7, 2024 /PRNewswire/ --  Immunovia (NASDAQ STOCKHOLM: IMMNOV), the pancreatic cancer diagnostics company, will present an update on its next-generation test at the annual meeting of the PRECEDE Consortium, a collaboration of 51 pancreatic centers worldwide conducting unprecedented research for the early detection of pancreatic cancer in individuals with increased risk for the disease.

Immunovia will share results from studies of its next-generation test to detect stage 1 and 2 pancreatic cancer, including the discovery study, model-development study, and analytical validation. As reported in a 1 August 2024 press release, the test demonstrated superior performance, with sensitivity of 85% and specificity of 98%, in the model-development study of 623 patient samples. In addition to presenting data on its next-generation test, Immunovia leaders will meet with PRECEDE researchers to discuss current research collaborations and future studies.

The annual meeting of the PRECEDE Consortium will bring together pancreatic cancer experts for two days of informational panels, partner updates, collaboration, and information sharing. Founded in 2020, the international PRECEDE Study is open to individuals with a family history of pancreatic cancer and/or those who carry genetic variants linked to development of the cancer. The PRECEDE Consortium's ambitious goal is to increase the five-year survival rate to 50% within the next 10 years through the most comprehensive observational longitudinal prospective cohort study of individuals at an elevated risk of developing pancreatic cancer. Researchers plan to enroll 10,000 patients; more than 7,000 are already participating.

"Our collaboration with PRECEDE has proven tremendously valuable. PRECEDE researchers provided hundreds of blood samples to support the current clinical validation study of our next-generation test," said Jeff Borcherding, Chief Executive Officer at Immunovia. He continued, "We are excited to update Consortium members and discuss ways we can collaborate to generate additional data on the accuracy and clinical use of our test. It's energizing to partner with a group that is so passionate about improving pancreatic cancer survival through early detection."

As communicated previously, Immunovia expects to complete the clinical validation study in December 2024 in preparation for launching its next-generation test for early detection of pancreatic cancer later in 2025.

For more information, please contact:

Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com  

Karin Almqvist-Liwendahl
CFO
karin.almqvist.liwendahl@immunovia.com

Immunovia in brief 

Immunovia AB 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 

CONTACT:

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Press release (PDF)

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SOURCE Immunovia AB

FAQ

What are the performance metrics of Immunovia's (IMMNOV) new pancreatic cancer test?

Immunovia's next-generation test demonstrated 85% sensitivity and 98% specificity in a model-development study of 623 patient samples.

When will Immunovia (IMMNOV) launch its next-generation pancreatic cancer test?

Immunovia plans to launch its next-generation test for early detection of pancreatic cancer in late 2025, following completion of clinical validation in December 2024.

How many centers are involved in the PRECEDE Consortium working with Immunovia (IMMNOV)?

The PRECEDE Consortium includes 51 pancreatic centers worldwide conducting research for early detection of pancreatic cancer.