On April 7, 2014 Myriad Genetics reported that it has submitted the first module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the use of BRACAnalysis testing as a companion diagnostic with olaparib (Press release Myriad Genetics, APR 7, 2014, View Source [SID:1234500382]). Olaparib is an investigational, orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca.
In 2012, Myriad made strides in developing BRACAnalysis as a companion diagnostic by retrospectively genotyping patients in a previously completed Phase 2 study of olaparib.
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