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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 NumberS048
Date Received06/04/2024
Decision Date07/02/2024
Product Code PQP 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approved for the removal of the companion diagnostic (CDx) indication for EXKIVITY (mobocertinib) for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertions from the Oncomine Dx Target Test label.
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