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July 1, 2021

Marlborough cancer testing lab a step closer to opening

Courtesy | Immunovia

Immunivia, a Swedish startup focused on the diagnosis of cancer and other autoimmune diseases, is one step closer to opening a Marlborough lab dedicated to the early detection of pancreatic cancer.

The company announced on Wednesday its American subsidiary Immunovia, Inc. has received a Clinical Laboratory Improvement Amendments Certificate of Registration. The certificate is a step in the accreditation process of Immunovia, Inc.'s Marlborough laboratory. The certification is required by federal law and is a prerequisite to receiving a clinical laboratory licensure from Massachusett’s Department of Public Health, which has the ability under CLIA to approve laboratories. The company filed its clinical laboratory license application with the state in April.

Immunovia plans to use the laboratory to test patients with the IMMrayTM PanCan-d test. When approved, the IMMray PanCan-d test will be the first blood test on the market dedicated to the early detection of pancreatic cancer, with all testing taking place at the Marlborough lab.

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