* BRACAnalysis CDx has been approved by the FDA for patients with breast and ovarian cancer who are or may become eligible for treatment with the PARP inhibitor Lynparza® (olaparib). BRACAnalysis CDx can also identify patients with ovarian cancer who may experience enhanced progression-free survival (PFS) from Zejula® (niraparib) maintenance therapy. myRisk, myChoice HRD and BRACAnalysis have not been reviewed or approved by the FDA.1,2
†Follow-up testing on a blood or saliva sample is recommended to determine whether a tumor BRCA1/2 mutation is germline (inherited) or somatic (isolated to the tumor).
- Intended Use: 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 breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza® (olaparib). Detection of deleterious or suspected deleterious germline BRCA variants by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) maintenance therapy. This assay is for professional use only and is to be performed only at 320 Wakara Way, Salt Lake City, UT 84108.
- For more detailed information about Lynparza and its safety and efficacy please go to lynparza.com
- For more detailed information about Zejula and its safety and efficacy please go to zejula.com
- Alsop, K. et al. (2012) BRCA mutation frequency and patterns of treatment response in BRCA mutation-positive women with ovarian cancer: a report from the Australian Ovarian Cancer Study Group. J. Clin. Oncol., 30, 2654–2663.