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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
PMA NumberP160045
Supplement NumberS035
Date Received03/08/2022
Decision Date08/11/2022
Product Code PQP 
Docket Number 22M-1951
Notice Date 08/19/2022
Advisory Committee Pathology
Clinical TrialsNCT03505710
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 indications for use to include a companion diagnostic indication for the detection of ERBB2 activating mutations (SNVs and exon 20 insertions) in non-small cell lung cancer patients who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2