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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceOncomine Dx Target Test
PMA NumberP160045
Supplement NumberS019
Date Received04/01/2020
Decision Date09/04/2020
Docket Number 20M-1988
Notice Date 11/20/2020
Advisory Committee Pathology
Clinical TrialsNCT03037385
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness