Tumor BRACAnalysis CDx regulatory update

Myriad Genetics received CE Mark approval for Tumor BRACAnalysis CDx to detect breast cancer 1 early onset (BRCA1) and BRCA2 mutations. The test, which is available in Europe through Myriad’s lab in Munich, Germany, can identify patients who may benefit from treatment with poly(ADP-ribose) polymerase (PARP) inhibitors, such as 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 BRCA1 and BRCA2 genes from whole blood. The test is approved in the U.S. (see BioCentury, Dec. 22, 2014). ...