Immunovia Completes Acquisition of Blood Samples for Test Validation
Immunovia, the innovative pancreatic cancer diagnostics company, has successfully acquired all necessary blood samples to clinically validate its next-generation test for pancreatic cancer. This significant achievement marks a crucial milestone in the company's journey toward completing a comprehensive clinical validation study.
Clinical Validation Study Overview
The primary goal of this extensive study is to affirm the sensitivity and specificity demonstrated in earlier model-development studies. It will employ a case-control approach to evaluate how accurately the new test distinguishes between blood samples from individuals diagnosed with early-stage pancreatic cancer and those who do not have the disease.
Blood Sample Collection Efforts
Immunovia successfully secured over 1,000 blood samples, with more than 200 collected from patients specifically diagnosed with stage 1 and stage 2 pancreatic cancer. Additionally, it gathered over 800 blood samples from high-risk individuals who do not currently have cancer. This study is set to be one of the largest validations of a pancreatic cancer biomarker test to date.
Collaboration with Leading Experts
The successful collection of samples involved leveraging established relationships with prominent researchers across pancreatic cancer centers in various regions. Notable contributors included Dr. Randall Brand from the University of Pittsburgh, Dr. Rosie Sears from Oregon Health and Science University, and Dr. Salvatore Paiella from the University of Verona.
Partnership with the PRECEDE Consortium
In another progressive step, this study represents Immunovia's inaugural collaboration with the Pancreatic Cancer Early Detection (PRECEDE) Consortium, an esteemed international group of experts. Led by Dr. Diane Simeone, the consortium collaborates intensively to enhance early detection of the disease. They provided nearly 500 samples from ongoing studies targeting individuals at high risk due to hereditary factors.
Importance of Early Detection
"Securing all samples required for clinical validation marks a momentous step in our mission to provide early pancreatic cancer detection to high-risk individuals," says Jeff Borcherding, CEO and President of Immunovia. He emphasized the importance of this study in facilitating early cancer intervention, which could significantly improve patient outcomes.
Future Plans for the Test
Immunovia anticipates completing the clinical validation study, allowing it to introduce the next-generation test aimed at early pancreatic cancer detection in high-risk populations. As previously indicated, the company expects to finalize this study by the end of 2024, paving the way for a launch in 2025.
About Immunovia
Immunovia AB is committed to improving survival rates for patients diagnosed with pancreatic cancer through early detection. The company prioritizes developing and commercializing straightforward blood tests that identify proteins and antibodies indicative of pancreatic cancer risk.
Building strong collaborations with healthcare providers, leading experts, and patient advocacy groups, Immunovia aims to ensure that its diagnostic tests become accessible to those facing elevated pancreatic cancer risks. It is critical to note that the USA remains the world's largest market for pancreatic cancer detection.
The company estimates that approximately 1.8 million individuals in the USA are at a high risk for pancreatic cancer and could significantly benefit from annual surveillance testing.
Contact Information
For further inquiries, individuals can reach out to:
Jeff Borcherding
CEO and President
Karin Almqvist Liwendahl
Chief Financial Officer
+46 709 11 56 08
Frequently Asked Questions
What is the aim of the clinical validation study?
The primary aim is to confirm the sensitivity and specificity of Immunovia's next-generation pancreatic cancer test and evaluate its accuracy in distinguishing between affected and unaffected individuals.
How many blood samples did Immunovia acquire?
Immunovia secured over 1,000 blood samples, with a significant portion coming from patients diagnosed at earlier stages and high-risk individuals without current cancer diagnoses.
What is the role of the PRECEDE Consortium?
The PRECEDE Consortium provides access to samples and collaboration aimed at enhancing early detection strategies for pancreatic cancer globally through shared expertise.
What does early detection mean for pancreatic cancer patients?
Early detection significantly improves the chances of successful intervention and treatment, which can help increase survival rates for those diagnosed with pancreatic cancer.
When does Immunovia plan to launch its new test?
Immunovia plans to complete its clinical validation study by the end of 2024, with the aim of launching the next-generation test for early detection of pancreatic cancer in 2025.
