BRACAnalysis CDx is an FDA-approved companion diagnostic test for BRCA1 and BRCA2 intended to be used as an aid in treatment decision making for LynparzaTM (olaparib), a PARP inhibitor.1


Personalizing Treatment Decisions in Ovarian Cancer

BRACAnalysis CDx is the first and only FDA-approved laboratory developed test (LDT) that indicates whether or not a patient with ovarian cancer may be eligible for treatment with the PARP inhibitor, Lynparza (olaparib).

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 the BRCA genes and providing patients with information about their own genetic profile. Increasing knowledge in the last several years about these genes has impacted individual patient’s medical management options and now mutations in BRCA1 and BRCA2 genes are one of the indications for treatment for patients with ovarian cancer.

Learn more about Myriad’s BRACAnalysis CDx

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 LynparzaTM (olaparib). 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.
Lynparza is a trademark of AstraZeneca