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Intended use
BRACAnalysis CDx is an FDA-approved test used to identify patients with germline BRCA1/2 mutations who may be eligible for certain targeted therapies without delay. This test quickly and accurately provides results for patients with pancreatic cancer, breast cancer, ovarian cancer, and prostate cancer who may benefit from PARP inhibitor treatment.
You and your patients need to know their germline BRCA1/2 status quickly to minimize anxiety while they wait for a result. BRACAnalysis CDx can report your patients’ germline BRCA1/2 status in less than two weeks after we receive the sample.
There is also a priority option for patients with pancreatic cancer with a one-week turnaround time. This accelerated process requires the use of the priority label for patients with pancreatic cancer.
43-63% of gBRCA mutations identified as VUSs at competing labs can be definitively classified using Myriad’s variant classification program.2
Myriad Genetic Laboratories has over 25 years of experience in variant classification and reclassification of BRCA1/2. The resulting analysis and interpretation of the variants reduces the VUS rate in genetic test results and provides confidence for oncologists when determining the appropriate therapy for their patients.
VUS = variant of uncertain significance
BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.
Results of the test are used as an aid in identifying patients who are or may become eligible for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations by BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) or Rubraca® (rucaparib) maintenance therapy.
This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108
Limitation: in ovarian cancer, ~70% of tumor BRCA1 and BRCA2 mutation positive patients are estimated to have a germline mutation while ~30% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from a patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in ovarian cancer patients does not rule out the possibility of a somatic BRCA1 and BRCA2 mutation in tumor tissue from these patients.
Limitation: in prostate cancer, ~50% of tumor BRCA1 and BRCA2 mutation positive patients are estimated to have a germline mutation while ~50% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in prostate cancer patients does not rule out the possibility of a somatic BRCA1 and BRCA2 mutation in tumor tissue from these patients.
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