Frequently Asked Questions

BRACAnalysis CDx

BRACAnalysis CDx™ FAQ

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Both BRACAnalysis and BRACAnalysis CDx sequence the BRCA1 and BRCA2 genes to determine if there are mutations in either of these genes. BRACAnalysis CDx is the only FDA approved laboratory developed test that indicates whether or not a patient with ovarian cancer may be eligible for treatment with Lynparza (olaparib). A positive BRACAnalysis CDx result in patients with ovarian cancer is also associated with enhanced progression-free survival (PFS) from Zejula (niraparib) maintenance therapy.
Myriad’s BRCA test was used to analyze samples in the clinical trials that led to the approval of Lynparza and Zejula. On that basis, the BRACAnalysis CDx test received FDA approval to inform patient management related to the PARP inhibitors Lynparza and Zejula. The FDA submission consisted of:
  • 17 non-clinical analytical verification studies
  • Six comparator studies
  • One clinical bridging study
  • Two extraction studies
  • Process validation study
  • Equipment and software validation
  • Two onsite laboratory inspections
  • Variant classification process
You can call Myriad at 1-800-469-7423 to order test kits or contact your local Myriad representative.
A small amount of blood is drawn and the sample is sent to Myriad for DNA sequencing and large rearrangement analysis of BRCA1 and BRCA2. Following analysis, variants are classified and a report is generated and sent to the ordering health care provider.
Results usually take less than two weeks and are sent to either the ordering healthcare provider or a designated “mail to” provider identified on the test request form.
BRACAnalysis CDx is broadly covered by the vast majority of health plans- in fact, most appropriate patients pay $0. Call Myriad at 1-800-469-7423 for more details.
Myriad myRisk® and CLIA BRACAnalysis® test both provide options for physicians in assessing BRCA status, but Myriad can only market BRACAnalysis CDx as the FDA approved BRCA testing for Lynparza and Zejula per regulation. If a patient’s BRCA status has been previously determined, it is at the physician’s discretion in the practice of medicine to retest or not. Factors that may influence whether a patient is retested include whether the patient had full sequencing and large rearrangement testing when their original test was performed.
BRACAnalysis CDx is the only FDA approved BRCA testing for Lynparza and Zejula. Patient samples submitted to Myriad that have been previously tested through another laboratory will receive the BRACAnalysis CDx test.

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