... Myriad recently submitted an investigational device exemption application with the US Food and Drug Administration for BRACAnalysis, laying the regulatory groundwork for the test to be studied in five pivotal trials to pick out best responders to AstraZeneca's PARP inhibitor olaparib, according to Pharmacogenomics Reporter. While it is Myriad's first IDE submission, the firm has companion diagnostic deals with several other biopharma firms, including Abbott Laboratories, Cephalon, BioMarin, and PharmaMar.
The agreement with Tesaro comes on the heels of the US Supreme Court's decision two weeks ago that isolated human genes are not patentable — a case that centered on Myriad's patents covering the BRCA1 and BRCA2 genes. The court, however, found that synthetic DNA is patent eligible.
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