|
Device | Oncomine Dx Target Test |
Applicant | LIFE TECHNOLOGIES CORPORATION 5781 VAN ALLEN WAY CARLSBAD, CA 92008 |
PMA Number | P160045 |
Supplement Number | S019 |
Date Received | 04/01/2020 |
Decision Date | 09/04/2020 |
Docket Number | 20M-1988 |
Notice Date | 11/20/2020 |
Advisory Committee |
Pathology |
Clinical Trials | NCT03037385
|
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 expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of RET fusions in non-small cell lung cancer patients who may benefit from treatment with GAVRETO (pralsetinib). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|