FDA has approved Illumina’s TruSight Oncology Comprehensive (TSO Comprehensive) test, a groundbreaking advancement in personalized cancer care.
The FDA also approved 2 companion diagnostic (CDx) indications for the TSO Comprehensive test, a first for a comprehensive genomic profiling IVD kit.
The first CDx indication identifies patients with solid tumors, both adults and children, who have neurotrophic tyrosine receptor kinase (NTRK) gene fusions, potentially making them eligible for treatment with Bayer’s VITRAKVI® (larotrectinib).
The second CDx indication targets adults with locally advanced or metastatic rearrangement during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) who may benefit from Lilly’s RETEVMO® (selpercatinib).
Everett Cunningham, CMO of Illumina knowedged FDA for approving TruSight Oncology Comprehensive with accompanying companion diagnostics for oncology customers and the community.
Cunningham emphasized Illumina’s commitment to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients.
Source: FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies
https://www.illumina.com/company/news-center/press-releases/press-release-details.html?newsid=cca694db-8cc7-4b6a-9449-38ccd9329816
