PMA P170019S054

Device: FoundationOne CDx
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S054
Product code: PQP
Decision date: 2025-01-16
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 BRAF V600 mutations and BRAF fusions in patients with pediatric low-grade glioma who may benefit from treatment with OJEMDA (tovorafenib).

Current openFDA PMA Record#

Device: FoundationOne CDx
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S054
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2025-01-16
Decision code: APPR
Date received: 2024-06-21
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 BRAF V600 mutations and BRAF fusions in patients with pediatric low-grade glioma who may benefit from treatment with OJEMDA (tovorafenib).