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Immunovia Receives Massachusetts Approval to Begin Testing of Patients for Pancreatic Cancer

NEW YORK ─ Swedish diagnostics company Immunovia said Wednesday that it has received final approval to begin patient testing for its Immray PanCan-d blood test for the early detection of pancreatic cancer.

The firm, a Lund University spinout, can immediately begin selling the Immray PanCan-d test for the early detection of pancreatic cancer in the US through its laboratory in Marlborough, Massachusetts.

The Massachusetts Department of Public Health approved Immunovia's test on Tuesday to test residents of that state, allowing its use throughout the US. Immunovia received its CLIA Certificate of Registration in June, the firm said. 

"The Immray PanCan-d test meets a huge clinical need and our ambition is to make the test available to individuals in all the high-risk groups for pancreatic cancer," Patrik Dahlen, Immunovia’s CEO, said in a statement. "As a first step, we will launch the test for the familial/hereditary high-risk group."

The Immray PanCan-d is a laboratory-developed test that recognizes biomarker signatures of the disease in the blood. It has the potential to significantly increase the survival of patients by detecting pancreatic cancer earlier when surgical resection is possible, Immunovia said.

Through the years, the firm has worked to improve the performance characteristics of the test, adding tumor protein biomarkers and carbohydrate antigen 19-9 to the immunoregulatory biomarkers it was already using in its panel.