SAN DIEGO, Calif., Oct. 27, 2015 — Agena Bioscience announced today the planned commercial launch of its CE-IVD marked MassARRAY® Dx PLUS assays for gene-specific mutation testing to aid in the selection of targeted therapy regimens. Agena Bioscience will introduce the first diagnostic kits in partnership with Diatech Pharmacogenetics. The MassARRAY Dx PLUS assays improve upon existing methods on the market, enabling highly multiplexed screening of actionable targets in a single assay, thereby dramatically reducing cost and turnaround time for testing laboratories.
MassARRAY Dx PLUS assays will provide parallel analysis of the most frequently observed and actionable mutations in colon, lung, or melanoma tumors. Labs can rapidly test for the most critical mutations in KRAS, NRAS, BRAF, EGFR, and ALK genes to drive better patient treatment outcomes.
Clinical practice guidelines, such as those set forth by the European Society of Medical Oncology, necessitate screening mutations in oncogenes such as EGFR and/or KRAS for targeted treatment. As personalized treatment has evolved with the discovery of new biomarkers, as well as the advent of novel cancer drugs, such as tyrosine kinase inhibitors, the number of actionable mutations has expanded. However, the lack of a cost-effective, practical method for screening in parallel has complicated the ease of introducing new mutations into clinical testing.
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