LUND, Sweden
, Oct. 7, 2024 /PRNewswire/ -- Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, today announces that the company has acquired all blood samples required to clinically validate its next-generation test for pancreatic cancer. Concluding the sample collection effort marks a key milestone toward successfully completing the clinical validation study.
The study seeks to confirm the sensitivity and specificity reported previously in the company's model-development study of its new test. The trial will be a case-control study evaluating the accuracy of the next-generation test in differentiating blood samples from people with early-stage pancreatic cancer from individuals without it.
Immunovia has secured over 1,000 blood samples, including over 200 from patients with stage 1 and 2 pancreatic cancer and more than 800 blood samples from high-risk individuals without cancer. The study will be one of the largest clinical validation studies of a pancreatic cancer biomarker test conducted to date.
Immunovia leveraged long-standing relationships with researchers at pancreatic cancer centers in Europe and North America to acquire the blood samples. Key collaborators who contributed an especially large number of samples included Dr. Randall Brand, University of Pittsburgh Department of Medicine; Dr. Rosie Sears, Oregon Health and Science University; and Dr. Salvatore Paiella, University of Verona.
This study marks Immunovia's first research collaboration with the Pancreatic Cancer Early Detection (PRECEDE) Consortium. The PRECEDE Consortium, led by Dr. Diane Simeone, is an international, multi-institutional collaborative group of experts working to improve early detection of pancreatic cancer through a novel model of collaboration and data sharing. The PRECEDE Consortium provided nearly 500 samples from its ongoing study of people at high-risk for hereditary cancer.
"We are excited to announce that we have secured all samples required to clinically validate our next-generation test. This study represents a pivotal step in our mission to bring early detection of pancreatic cancer to high-risk individuals," says Jeff Borcherding, CEO and President of Immunovia.
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
Chief Financial Officer
karin.almqvist.liwendahl@immunovia.com
+46 709 11 56 08
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
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