Recent Device Approvals: BRACAnalysis CDx

The FDA has recently approved BRACAnalysis CDx to be marketed.  BRACAnalysis CDx is a laboratory test that detects the presence of mutations in the BRCA1 and BRCA2 genes in blood samples from patients with ovarian cancer. The BRCA genes in normal cells play an important role in repairing damaged DNA and work to suppress tumor growth.  If defective BRCA genes are detected, then patients may be considered for treatment with Lynparza (olaparib).

Lynparza (olaparib) is a new drug for women with previously treated ovarian cancer who have mutated BRCA genes, as detected by the BRACAnalysis CDx.  Lynparza (olaparib) blocks proteins involved in important cell functions, such as repairing damaged DNA.  BRACAnalysis CDx is used to detect specific types of mutations in the BRCA1 or BRCA2 genes to select patients for treatment with Lynparza (olaparib).

For more information, please see: http://wcms.fda.gov/FDAgov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm428428.htm


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