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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 Express Test
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantLife Technologies Corporation
7335 Executive Way
Frederick, MD 21704
PMA NumberP240040
Supplement NumberS005
Date Received03/13/2026
Decision Date09/09/2026
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT06760819
Supplement TypePanel 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 indications for use to include a companion diagnostic (CDx) 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 (NSCLC) who may benefit from treatment with HYRNUO® (sevabertinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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