Myriad Blog

BRACAnalysis CDx™ is the First and Only FDA-Approved Test to Assess BRCA Status in Ovarian Cancer Patients*

FDA_BRAC_Header

Myriad Genetics announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza™ (olaparib). Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy.

BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic for use with a novel PARP inhibitor.

“Myriad is excited to offer the first and only FDA-approved companion diagnostic for Lynparza, which we believe opens a new door in personalized medicine and represents a big step forward in tailoring treatment for women with ovarian cancer,” said Mark Capone, president, Myriad Genetic Laboratories. “Less than 25 percent of ovarian cancer patients know their germline BRCA status, which is critical for any ovarian cancer patient who may be considered for treatment with Lynparza.”

The approval of BRACAnalysis CDx demonstrates Myriad’s commitment to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.

To order BRACAnalysis CDx, download a Test Request Form and include it in any BRACAnalysis®blood draw test kit or order a BRACAnalysis CDxTMtest kit.

For more information, please visit: www.myriadpro.com/BRACAnalysis-CDx

Download the press release here

 *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 eligible for treatment with Lynparza™ (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.

 

Myriad, the Myriad logo, MyriadPro, the MyriadPro logo, Myriad myRisk Hereditary Cancer, the Myriad myRisk Hereditary Cancer logo, Myriad myPath Melanoma, the Myriad myPath Melanoma logo, Myriad myPlan Lung Cancer, the Myriad myPlan Lung Cancer logo, BRACAnalysis, the BRACAnalysis logo, COLARIS, the COLARIS logo, COLARIS AP, the COLARIS AP logo, MELARIS, the MELARIS logo, PANEXIA, the PANEXIA logo, Prolaris, the Prolaris logo, ResultsNow, the ResultsNow logo, Myriad Promise, and the Myriad Promise logo are either trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other jurisdictions.