PMA P230011

Device: TruSight Oncology Comprehensive
Applicant: Illumina, Inc.
Product code: PQP
Decision date: 2026-08-14
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
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).

Current openFDA PMA Record#

Device: TruSight Oncology Comprehensive
Applicant: Illumina, Inc.
PMA number: P230011
Supplement: S006
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-08-14
Decision code: APPR
Date received: 2025-11-18
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).