|
Device | BRACAnalysis CDx® |
Generic Name | Cancer-related germline gene mutation detection system |
Applicant | MYRIAD GENETIC LABORATORIES 320 Wakara Way Salt Lake City, UT 84108 |
PMA Number | P140020 |
Supplement Number | S025 |
Date Received | 10/18/2022 |
Decision Date | 11/16/2022 |
Product Code |
PJG |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the removal of the companion diagnostic indication for BRACAnalysis CDx to identify patients with ovarian, fallopian tube, or primary peritoneal cancer with homologous recombination deficiency (HRD) positive status for treatment with Lynparza® (olaparib) and Rubraca® (rucaparib). |