LUND, SWEDEN – Immunovia, a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, today announced further details regarding the outcomes of the Verification Study.
As previously communicated, the Verification study is the step in the development process where samples are run on the final commercial product with the locked biomarker signature that was derived from the previous Commercial Test Model Study. The Verification Study included samples collected from six sites in Europe and three sites in the US, which mirrors the clinical and commercial setting. In total 519 samples were analyzed, including 81 PDAC Stage I/II and 114 PDAC Stage III/IV, 212 healthy and 112 symptomatic controls.
As announced last week, the results showed accuracy of 94% in differentiating early stage I/II PDAC patients from healthy controls. We now report a specificity of 99% and a sensitivity of 78% for this comparison, yielding a high NPV of 0.993, which minimize the number of false positive. Early stages I/II PDAC were differentiated from all the controls with an accuracy of 91%, with a now reported specificity of 93% and a sensitivity of 78%, yielding an NPV of 0.993. The analysis was performed with the locked commercial signature, without any re-training procedure, to again mirror the commercial setting.
All samples fulfilled the inclusion criteria and no samples were replaced after the test had been completed, ensuring that no confounding factors affected the outcome. The results of the Verification Study pave the way for the final Validation Study, with a reported sales start at the end of Q1 2021 with subsequent commercial testing in Q2.
This is information that Immunovia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 19:50 CET on November 2, 2020.
For more information, please contact:
Julie Silber, Director of Investor Relations, Immunovia
Tel: +46 7 93 486 277
Immunovia AB is a diagnostic company that is developing and commercializing highly accurate blood tests for the early detection of cancer and autoimmune diseases based on Immunovia’s proprietary test platform called IMMray™. Tests are based on antibody biomarker microarray analysis using advanced machine-learning and bioinformatics to single-out a set of relevant biomarkers that indicate a certain disease. Thus, forming a unique “disease biomarker signature”.
The company was founded in 2007, based on cancer studies and ground-breaking research in the Department of Immuntechnology at Lund University and CREATE Health Cancer Center, Sweden.
The first product, IMMray™ PanCan-d, is undergoing clinical evaluation in some of the world’s largest clinical studies for pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1 and is currently in the final validation phase. The company aims for a sales start at the end of Q1 2021 with subsequent commercial testing in Q2.
When validated, IMMray™ PanCan-d will be the first blood-based test for early diagnosis of pancreatic cancer on the market, with a potential to significantly improve patient survival and outcome.
Immunovia Dx Laboratories located in Marlborough, Massachusetts, USA and Lund, Sweden will provide laboratory testing services in two accredited reference laboratories.
Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.