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| Device | TruSight Oncology Comprehensive |
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| Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
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| Applicant | Illumina, Inc.
5200 Illumina Way
San Diego, CA 92122 |
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| PMA Number | P230011 |
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| Date Received | 03/20/2023 |
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| Decision Date | 08/21/2024 |
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| Product Code |
PQP |
| Advisory Committee |
Pathology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina® NextSeq™ 550Dx instrument. The test can be used to detect single nucleotide variants, multi- nucleotide variants, insertions, and deletions from DNA, and fusions in 24 genes and splice variants in one gene from RNA. The test also reports a Tumor Mutational Burden (TMB) score.The test is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapies listed in Table 1, in accordance with the approved therapeutic product labeling. In addition, the test is intended to provide tumor profiling information for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Genomic findings other than those listed in Table 1 of the intended use statement are not conclusive or prescriptive for labeled use of any specific therapeutic product. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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