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Immunovia Receives Pennsylvania, Maryland Clinical Lab Permits

NEW YORK – Swedish diagnostic firm Immunovia announced on Monday that it has received clinical laboratory permits from the Pennsylvania and Maryland departments of health to launch its pancreatic cancer blood test.

The permits allow physicians in both states to order the firm's ImmRay PanCan-d test, which detects stage I and stage II pancreatic cancer in at-risk patients. With the new permits the company can now offer the test in 48 states, Jeff Borcherding, CEO of Immunovia's US subsidiary, said in a statement. 

The subsidiary received clinical laboratory licensure from the Rhode Island Department of Health for its test last week. The assay was launched in the US in August 2021 after approval from the Massachusetts Department of Public Health.

The microarray-based blood test detects nine serum biomarkers of pancreatic ductal adenocarcinoma that are then analyzed using a proprietary algorithm to determine a cancer risk classification.