|
Device | FoundationOne CDx |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Foundation Medicine, Inc. 150 Second Street, 1st Floor Cambridge, MA 02141 |
PMA Number | P170019 |
Supplement Number | S037 |
Date Received | 08/12/2022 |
Decision Date | 05/26/2023 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the clinical protocol entitled Statistical Analysis Plan for Real-World Evidence Study Supporting FoundationOne®CDx as a Companion Diagnostic for Entrectinib in Non-Small Cell Lung Cancer Patients with ROS1 Fusions |