Illumina’s cancer biomarker test approved by FDA

Illumina announced FDA approval of its in vitro diagnostic TruSight Oncology Comprehensive test and its first 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. TSO Comprehensive is FDA approved as a CDx 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. 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. TSO Comprehensive will begin shipping to customers this year. A separate CE-marked version of TSO Comprehensive is already available in Europe, launched in 2022.