|
Device | FoundationOne Liquid CDx |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Foundation Medicine Inc. 150 Second Street Cambridge, MA 02141 |
PMA Number | P190032 |
Supplement Number | S015 |
Date Received | 11/01/2023 |
Decision Date | 11/14/2024 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval order to expand the intended use of FoundationOne Liquid CDx (F1LCDx) (P190032/S015) to include a companion diagnostic indication to identify patients with non-small cell lung cancer harboring MET single nucleotide variants (SNVs) and insertions and deletions (indels) that lead to MET exon 14 skipping alterations who are eligible for treatment with Tepmetko® (tepotinib). |