Diagnostic Tests For Lung And Colon Cancer Launched In Europe

A unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing for cancer has now become available to molecular pathologists.

The multiplexed assays allow the user to concurrently analyze the relevant oncogenes and thereby reduce cost and turnaround time compared to existing methods. The two test panels support personalized treatment and improved patient care through rapid analysis of clinically actionable mutations implicated in lung and colon cancer.

Agena Bioscience (San Diego, CA; USA) has launched its Conformité European In Vitro Diagnostic Medical Devices (CE-IVD) marked MassARRAY Dx products in Europe. Two targeted diagnostic panels will be sold, the MassARRAY Dx Lung Panel and the MassARRAY Dx Colon Panel, in addition to the company’s MassARRAY Dx instrumentation.

The MassARRAY Dx Colon Panel simultaneously analyzes over 200 mutations in the four major oncogenes involved in the pathogenesis of colorectal cancer (KRAS, BRAF, NRAS, and PIK3CA), using less than 40 ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue. The MassARRAY Dx Lung Panel simultaneously analyzes over 300 mutations in 10 genes implicated in the pathogenesis of lung cancer (EGFR, KRAS, BRAF, PIK3CA, NRAS, ALK, ERBB2, DDR2, MAP2K1, and RET), using less than 40ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue.

The CE-IVD marked MassARRAY Dx products, consisting of the MassARRAY Dx Colon Panel, MassARRAY Dx Lung Panel, and MassARRAY Dx instrumentation (MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser RS 1000), are sold exclusively in Europe for diagnostic use, and are not available for sale in the USA. Peter M. Dansky, MS, MBA, Chief Executive Officer of Agena Bioscience, said, “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. 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.”

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