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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 NumberS027
Date Received02/22/2021
Decision Date12/01/2021
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT02609776
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 EGFR exon 20 insertion mutations in non-small cell lung cancer patients who may benefit from treatment with RYBREVANT (amivantamab-vmjw).
Post-Approval StudyShow Report Schedule and Study Progress
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