PMA P170019S062

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S062
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 to include a companion diagnostic (CDx) indication for the detection of PIK3CA mutations in patients with locally advanced or metastatic breast cancer who may benefit from treatment with ITOVEBITM (inavolisib) in combination with palbociclib and fulvestrant.

Current openFDA PMA Record#

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S062
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: 2024-11-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval order to expand the intended use of FoundationOne CDx to include a companion diagnostic (CDx) indication for the detection of PIK3CA mutations in patients with locally advanced or metastatic breast cancer who may benefit from treatment with ITOVEBITM (inavolisib) in combination with palbociclib and fulvestrant.