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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceBRACAnalysis CDx
Generic NameCancer-related germline gene mutation detection system
320 Wakara Way
Salt Lake City, UT 84108
PMA NumberP140020
Supplement NumberS020
Date Received12/06/2019
Decision Date05/19/2020
Product Code PJG 
Advisory Committee Pathology
Clinical TrialsNCT02987543
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to expand the intended use of BRACAnalysis® CDx to include a companion diagnostic indication for BRCA1/2 mutations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza® (olaparib).