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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.
 
DeviceTruSight Oncology Comprehensive
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantIllumina, Inc.
5200 Illumina Way
San Diego, CA 92122
PMA NumberP230011
Supplement NumberS006
Date Received11/18/2025
Decision Date08/14/2026
Product Code PQP 
Docket Number 26M-9490
Notice Date 08/14/2026
Advisory Committee Pathology
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 intended use of the TruSight Oncology Comprehensive to include a companion diagnostic indication to identify RET fusions in thyroid cancer (TC) patients and RET small DNA variant mutations in medullary thyroid cancer (MTC) patients who may benefit from treatment with RETEVMO® (selpercatinib).
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