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Illumina's TruSight Oncology Biomarker Test Gets FDA Approval
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Illumina's TruSight Oncology Biomarker Test Gets FDA Approval
Aug 29, 2024 4:09 AM

10:34 AM EDT, 08/27/2024 (MT Newswires) -- Illumina ( ILMN ) said Tuesday its TruSight Oncology comprehensive test secured approval from the Food and Drug Administration as an in vitro diagnostic.

The FDA also approved the test's first two companion diagnostic indications, the company said.

The test examines over 500 genes in a solid tumor to boost the chances of finding immuno-oncology or clinically actionable biomarkers, aiding in targeted therapy and clinical trial eligibility.

TruSight Oncology is FDA-approved as a companion diagnostic to identify patients with solid tumors who have neurotrophic tyrosine receptor kinase gene fusions, which could benefit from treatment with Bayer's Vitrakvi, Illumina ( ILMN ) said. The company also said the test is approved for identifying adult patients with a form of non-small-cell lung cancer which could benefit from treatment with Eli Lilly's ( LLY ) Retevmo.

TSO Comprehensive is expected to begin shipping to customers later this year, Illumina ( ILMN ) said.

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