PMA P140020S025

Device: BRACAnalysis CDx®
Applicant: Myriad Genetic Laboratories
PMA number: P140020
Supplement: S025
Product code: PJG
Decision date: 2022-11-16
Generic name: Cancer-related germline gene mutation detection system
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).

Current openFDA PMA Record#

Device: BRACAnalysis CDx®
Applicant: Myriad Genetic Laboratories
PMA number: P140020
Supplement: S025
Product code: PJG
Generic name: Cancer-related germline gene mutation detection system
Decision date: 2022-11-16
Decision code: APPR
Date received: 2022-10-18
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).