BRACAnalysis CDx regulatory update

FDA approved a PMA from Myriad for BRACAnalysis CDx as the only companion diagnostic for ovarian cancer drug Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.). The in vitro diagnostic qualitatively detects and classifies variants in the protein coding regions and intron/exon boundaries of the breast cancer 1 early onset (BRCA1) and BRCA2 genes from whole blood. BRACAnalysis CDx is the first FDA-approved companion diagnostic for Lynparza, a poly(ADP-ribose) polymerase (PARP) inhibitor. ...