BRACAnalysis CDx is an FDA-approved laboratory developed test for BRCA1 and BRCA2 intended to inform patient management related to the PARP inhibitors, Lynparza™ (olaparib) and Zejula™ (niraparib). ™ 1,2,3
Personalizing Treatment Decisions in Ovarian Cancer
Mutations in BRCA1 and BRCA2 are known to cause Hereditary Breast and Ovarian Cancer (HBOC) Syndrome. For more than 20 years, Myriad has been dedicated to understanding mutations in these genes as well as reducing the overall variant of uncertain significance rate to ensure that all patients receive answers. Increasing knowledge over the last several years about these genes has changed medical management and now mutations in BRCA1 and BRCA2 genes are used to inform patient management related to the PARP inhibitors LynparzaTM (olaparib) and ZejulaTM (niraparib). 2,3
For Physicians: learn more about Myriad’s BRACAnalysis CDx
For Patients: learn more about Myriad’s BRACAnalysis CDx
1. 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 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.
2. For more detailed information about Lynparza and its safety and efficacy please go to lynparza.com
3. For more detailed information about Zejula and its safety and efficacy please go to zejula.com
Lynparza is a trademark of the AstraZeneca group of companies. Zejula is a trademark of Tesaro, Inc.