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 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.
Table 1: Companion diagnostic indications
Indication Biomarker Therapy Breast Cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes Lynparza® (olaparib)
Ovarian Cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes Lynparza® (olaparib)
Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 variants by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) or with 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 or 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 patient’s blood samples. A negative result using the BRACAnalysis CDx blood test in ovarian cancer patients does not rule out the possibility of a somatic BRCA1 or BRCA2 mutation in tumor tissue from these patients.
- 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
- NCCN® Invasive Breast Cancer V3.2017 BINV-O1
- Robson et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med (2017). 377:523-533
Lynparza is a registered trademark of the AstraZeneca group of companies. Zejula is a registered trademark of Tesaro, Inc.
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment.