|
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 | S016 |
Date Received | 12/19/2023 |
Decision Date | 08/30/2024 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Clinical Trials | NCT03732820
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval order to expand the intended use of FoundationOne CDx (F1CDx) (P170019/S052) and FoundationOne Liquid CDx (F1LCDx) (P190032/S016) to include a companion diagnostic indication to identify patients with prostate cancer with BRCA1/2 alterations for the treatment with LYNPARZA (olaparib) in combination with abiraterone. |