|
Device | FoundationOne Liquid CDx (F1LCDx) |
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 | S004 |
Date Received | 04/13/2022 |
Decision Date | 12/22/2022 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to include a companion diagnostic indication for NTRK1, NTRK2, and NTRK3 fusions in patients with solid tumors and for ROS1 fusions in patients with non-small cell lung cancer who may benefit from treatment with ROZLYTREK® (entrectinib). |