Illumina’s TrusSight Test OK'd as Companion Diagnostic

FDA has approved an llumina PMA for its in vitro diagnostic TruSight Oncology Comprehensive test for two companion diagnostic indications. This single test “interrogates” over 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,” the company says.

The approval covers identifying 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), Illumina says. The test is also approved to identify adult patients with locally advanced or metastatic rearranged during transfection fusion-positive non-small-cell lung cancer that may benefit from treatment with Lilly's Retevmo (selpercatinib).