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Agena Receives CE-IVD Marking, Launches MassArray Cancer Tests in Europe

NEW YORK (GenomeWeb) – Agena Bioscience said today that it has launched diagnostic panels for lung and colon cancer in Europe, as well as related instrumentation, after receiving CE-IVD marking for the tests. 

The tests are based on the company's MassArray DX system and are being marketed in partnership with Diatech Pharmacogenetics, which began working with Agena late last year to commercialize in vitro cancer diagnostics in Europe.

"Our entry into the European clinical diagnostics market is a pillar of Agena's global strategy to grow its clinical business with targeted, clinically actionable tests," Agena CEO Pete Dansky said in a statement. "The MassArray Dx Lung and Colon Panels will provide rapid and reliable diagnostic results to help physicians select the most effective treatments for their oncology patients." 

The colon test analyzes over 200 mutations in four major colon cancer-associated oncogenes, while the lung panel analyzes over 300 mutations in 10 genes implicated in lung cancer. The tests are not available for sale in the US, although Agena has previously expressed interested in developing US Food and Drug Administration-cleared diagnostics.