PMA P190014

Device: MyChoice® CDx
Applicant: Myriad Genetic Laboratories, Inc.
PMA number: P190014
Supplement: S007
Product code: PJG
Decision date: 2026-03-10
Generic name: Cancer-related germline gene mutation detection system
Approval order statement: Approval to update the MyChoice CDx assay labeling from a complementary diagnostic to a companion diagnostic to aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline or somatic BRCA1 and BRCA2 mutations and/or a positive genomic instability score, who are eligible or may become eligible for treatment with Zejula (niraparib).

Current openFDA PMA Record#

Device: MyChoice® CDx
Applicant: Myriad Genetic Laboratories, Inc.
PMA number: P190014
Supplement: S011
Product code: PJG
Generic name: Cancer-related germline gene mutation detection system
Decision date: 2026-03-10
Decision code: APPR
Date received: 2025-09-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to update the MyChoice CDx assay labeling from a complementary diagnostic to a companion diagnostic to aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline or somatic BRCA1 and BRCA2 mutations and/or a positive genomic instability score, who are eligible or may become eligible for treatment with Zejula (niraparib).