* 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
Breast Cancer Publications
In the OlympiAD Trial, in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation, olaparib monotherapy provided a significant benefit over standard therapy by reducing the risk of disease progression or death by 42%. This practice-changing evidence highlights the need for the identification and testing of all appropriate patients for hereditary breast cancer to identify the BRCA mutation carriers in order to inform therapeutic decisions. Additionally, trials such as TNT and GeparSixto highlight the clinical utility of knowing BRCA1/2 status in patients when making treatment decisions related to DNA-damaging chemotherapy. Explore these publications to learn more about how BRCA1/2 can impact treatment decisions related to PARP inhibitor therapy and DNA-damaging chemotherapy.4
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
- 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.