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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
Carlbad, CA 92008
PMA NumberP160045
Supplement NumberS050
Date Received04/22/2025
Decision Date11/19/2025
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT06760819
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 include a companion diagnostic indication for the detection of ERBB2/HER2 activating mutations (SNVs in exons 18-21 within the tyrosine kinase domain and exon 20 insertions) in patients with non-small cell lung cancer who may benefit from treatment with HYRNUO® (sevabertinib).
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