Immunovia has successfully acquired all blood samples required to clinically validate its next-generation test for pancreatic cancer
Rhea-AI Summary
Immunovia (IMMNOV: Nasdaq Stockholm) has successfully acquired all blood samples needed to clinically validate its next-generation test for pancreatic cancer. The company has secured over 1,000 blood samples, including 200+ from early-stage pancreatic cancer patients and 800+ from high-risk individuals without cancer. This marks a key milestone towards completing one of the largest clinical validation studies of a pancreatic cancer biomarker test to date.
The study aims to confirm the sensitivity and specificity of Immunovia's new test in differentiating early-stage pancreatic cancer samples from those without cancer. Collaborators include researchers from the University of Pittsburgh, Oregon Health and Science University, University of Verona, and the Pancreatic Cancer Early Detection (PRECEDE) Consortium. Immunovia expects to complete the study in December 2024 and launch the test later in 2025.
Positive
- Successfully acquired over 1,000 blood samples for clinical validation study
- Collaboration with prestigious research institutions and PRECEDE Consortium
- On track to complete clinical validation study by December 2024
- Planned launch of next-generation pancreatic cancer detection test in 2025
- Potential to improve early detection of pancreatic cancer in high-risk individuals
Negative
- None.
Insights
Immunovia's completion of blood sample collection for clinical validation of their next-generation pancreatic cancer diagnostic test represents a critical development milestone, though not yet a definitive value inflection point. The company has secured over 1,000 samples - including 200+ from early-stage pancreatic cancer patients and 800+ from high-risk individuals without cancer - positioning this as one of the largest validation studies for pancreatic cancer biomarkers to date.
What elevates the significance of this achievement is Immunovia's collaboration with the Pancreatic Cancer Early Detection (PRECEDE) Consortium and established research centers across North America and Europe. These relationships provide scientific credibility and potentially streamline the path to clinical adoption if validation proves successful.
The December 2024 timeline for completing clinical validation aligns with their projected 2025 commercial launch. However, investors should recognize this represents an intermediary step rather than guaranteed market success. The true value inflection point will come when validation results confirm whether the test maintains the sensitivity and specificity demonstrated in earlier development studies.
Early pancreatic cancer detection addresses a substantial unmet need, with the company estimating 1.8 million high-risk individuals in the US alone who could benefit from annual surveillance testing. This suggests significant market potential if validation succeeds, but regulatory hurdles and reimbursement considerations remain before realizing commercial value.
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
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.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com
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SOURCE Immunovia AB
FAQ
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