LUND, SWEDEN – Immunovia, a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, today announced positive results from the verification study and will now commence the validation study, the last step towards the launch of IMMray™ PanCan-d. The verification study analysis shows results in line with the previous commercial test model study (CTMS), which paves the way for the final blinded validation study.
“We are very pleased with the results of the verification study and are now commencing the preparation for the validation process, while finishing up some bioinformatics for all subgroups of samples,” said Mats Grahn, CEO. “These results will be made public as soon as the study is completed in all its details. We remain fully committed to the launch of IMMray™ PanCan-d and are now only one step away from the Q4 start sales of IMMray™ PanCan-d.”
About the Verification Study
The study was performed in order to verify the IMMray™ PanCan-d commercial biomarker signature using known samples and to further validate its accuracy in differentiating PDAC (pancreatic ductal adenocarcinoma) stages I through IV vs. controls that best mirror the clinical, commercial setting situation (i.e. patients with non-specific but concerning symptoms). All the samples were freshly collected through our Key Opinion Leaders (KOL) at pancreatic diseases reference sites in USA and Europe. The verification study precedes the final blinded validation study required for sales start.
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 08:30 CET on September 29, 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 for sales start Q4 2020. 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.