PMA P170019S067

Device: FoundationOne CDx
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S067
Product code: PQP
Decision date: 2026-05-12
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 MET exon 14 skipping alterations in advanced or metastatic NSCLC patients who may benefit from treatment with TEPMETKO® (tepotinib)

Current openFDA PMA Record#

Device: FoundationOne CDx
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S067
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-05-12
Decision code: APPR
Date received: 2025-07-14
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 (F1CDx) to include a companion diagnostic (CDx) indication for the detection of MET exon 14 skipping alterations in advanced or metastatic NSCLC patients who may benefit from treatment with TEPMETKO® (tepotinib)