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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
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantLIFE TECHNOLOGIES CORPORATION
5781 VAN ALLEN WAY
CARLSBAD, CA 92008
PMA NumberP160045
Supplement NumberS025
Date Received12/14/2020
Decision Date09/29/2023
Product Code PQP 
Advisory Committee Pathology
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 the BRAF V600E positive anaplastic thyroid cancer patients (ANA) for dabrafenib and tramatenib (Mekinist/Tafinlar).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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