June 30th, 2021

Immunovia, Inc. Receives Certificate of Registration – Clinical Laboratory Licensure Still Pending

LUND, SWEDEN – Immunovia AB (publ) (“Immunovia”), a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, today announced that its American subsidiary Immunovia, Inc. has received CLIA Certificate of Registration Number 22D2227265. 

The Certificate of Registration is a critical step in the accreditation process of Immunovia, Inc.’s laboratory outside Boston. The Certificate of Registration is required by federal law and is a prerequisite to receiving a clinical laboratory licensure from Massachusetts Department of Public Health, which has the ability under CLIA to approve laboratories.

Clinical laboratory licensure is required before Immunovia can begin testing patients with the IMMrayTM PanCan-d test. Immunovia is awaiting approval of the clinical laboratory license application which was filed with the Massachusetts Department of Public Health Clinical Laboratory Program in April. When approved, the IMMray PanCan-d test will be the first blood test on the market dedicated to the early detection of pancreatic cancer, which will be exclusively provided from Immunovia, Inc., Marlborough, Massachusetts, USA.

“We are of course disappointed that the license process has been much slower than normal due to a high workload at Massachusetts Department of Public Health, as a result of the pandemic. This kind of delays are out of our control and has also impacted our planned announcement of the European launch plan. We now look forward to obtain the final clinical laboratory licensure and the sales force is ready to launch,” said Patrik Dahlen, CEO of Immunovia.

For more information, please contact:
Patrik Dahlen, CEO Immunovia
Email: patrik.dahlen@immunovia.com
Tel: +46 73 376 76 64

About Immunovia
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. The final validation study was completed in Q1 2021. The accreditation process for Immunovia, Inc. in Marlborough, Massachusetts, USA is ongoing and commercial testing will begin after the accreditation.

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. The test will be exclusively provided from Immunovia, Inc., Marlborough, Massachusetts, USA.

Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.


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