Illumina, Inc. (ILMN) announced on Tuesday that it has received FDA approval for its TruSight Oncology (TSO) Comprehensive in vitro diagnostic (IVD) test, alongside its first two companion diagnostic (CDx) indications.This innovative test analyzes over 500 genes to profile a patient’s solid tumor, significantly enhancing the chances of identifying immuno-oncology biomarkers or other clinically actionable markers that can guide targeted therapy or clinical trial participation.The FDA has approved TSO Comprehensive as a companion diagnostic for identifying adult and pediatric patients with solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions, who may benefit from treatment with Bayer’s VITRAKVI (larotrectinib).Additionally, the test is approved to detect adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC), who could benefit from treatment with Lilly’s RETEVMO (selpercatinib).”FDA approval for TruSight Oncology Comprehensive, along with its companion diagnostics, represents a significant milestone for our oncology clients and community,” said Everett Cunningham, Chief Commercial Officer of Illumina. “We are dedicated to collaborating with industry leaders like Bayer and Lilly to advance cancer diagnostics and expand access to precision oncology for more patients.”The material has been provided by InstaForex Company – www.instaforex.com
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