September 2024—Illumina announced Food and Drug Administration approval of its in vitro diagnostic TruSight Oncology Comprehensive test and its first two companion diagnostic indications. This single test interrogates more than 500 genes to profile a patient’s solid tumor, helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment.
TSO Comprehensive is FDA approved as a companion diagnostic to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase gene fusions that may benefit from treatment with Bayer’s Vitrakvi (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer that may benefit from treatment with Lilly’s Retevmo (selpercatinib).
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