|
Device | FoundationOne Liquid CDx (F1 Liquid CDx) - based Clinical Trial Assay |
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 | S008 |
Date Received | 09/26/2022 |
Decision Date | 12/19/2022 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | real-time process |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for FoundationOne® Liquid CDx (FILCDx) label expansion to obtain companion diagnostic group labeling claim for patients with non-small cell lung cancer harboring EGFR exon 19 deletions or EGFR exon 21 L858R mutations for treatment with any one of the FDA-approved EGFR Tyrosine Kinase Inhibitors (TKI). |