Immunovia AB, a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, 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 IMMray 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. These 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.