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Medical Devices

BRACAnalysis CDx - P140020

Picture of the device.

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: BRACAnalysis CDx
Applicant: Myriad Genetic Laboratories, Inc.
Address: 320 Wakara Way, Salt Lake City, UT 84108
Approval Date: December 19, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140020a.pdf

What is it? BRACAnalysis CDx is a laboratory test that detects the presence of mutations in the BRCA1 and BRCA2 genes in blood samples from patients with ovarian cancer. The BRCA genes in normal cells play an important role in repairing damaged DNA and work to suppress tumor growth.  If defective BRCA genes are detected, then patients may be considered for treatment with Lynparza (olaparib).  

Lynparza (olaparib) is a new drug for women with previously treated ovarian cancer who have mutated BRCA genes, as detected by the BRACAnalysis CDx.  Lynparza (olaparib) blocks proteins involved in important cell functions, such as repairing damaged DNA.  BRACAnalysis CDx is used to detect specific types of mutations in the BRCA1 or BRCA2 genes to select patients for treatment with Lynparza (olaparib).

How does it work?

  • A healthcare professional takes a blood sample from a patient with ovarian cancer, and the sample is sent to Myriad Genetic Laboratories, Inc. in Salt Lake City, UT.
  • At Myriad Genetic Laboratories, Inc., DNA is isolated from the blood sample, and then mixed with reagents that specifically detect and make copies of (amplify) regions in the BRCA1 and BRCA2 genes. The amplified products are then analyzed and confirmed for the presence or absence of mutations.
  • A trained medical professional reviews the results, and then a report is sent to the ordering doctor.
  • The presence of mutations resulting in defective BRCA gene products indicates that a patient may be selected for treatment with Lynparza (olaparib).

When is it used? BRACAnalysis CDx is used to determine if a patient previously treated for ovarian cancer may be a candidate for treatment with Lynparza (olaparib).

What will it accomplish? BRACAnalysis CDx helps to determine if a patient with ovarian cancer may be eligible for treatment with Lynparza (olaparib).

When should it not be used? Patients who have previously had a bone marrow transplant should not be tested with the BRACAnalysis CDx.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Page Last Updated: 01/11/2016
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