PMA P170019S060

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S060
Product code: PQP
Decision date: 2026-05-27
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval order to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of HRR gene alterations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C) in patients with metastatic castrate-resistant prostate cancer (mCRPC) who may benefit from treatment with TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide).

Current openFDA PMA Record#

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S060
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-05-27
Decision code: APPR
Date received: 2024-09-20
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval order to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of HRR gene alterations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C) in patients with metastatic castrate-resistant prostate cancer (mCRPC) who may benefit from treatment with TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide).