Illumina, Inc., a leader in DNA sequencing technologies, has received FDA approval for its TruSight™ Oncology (TSO) Comprehensive test, an in vitro diagnostic (IVD) that profiles over 500 genes in solid tumors. This comprehensive test includes two companion diagnostic (CDx) indications, enabling the identification of specific gene fusions in cancer patients that can be treated with targeted therapies. One of the key features of the TSO Comprehensive test is its ability to detect neurotrophic tyrosine receptor kinase (NTRK) gene fusions in both adult and pediatric patients, as well as rearranged during transfection (RET) fusions in non-small-cell lung cancer (NSCLC) patients.
The test's approval marks a significant milestone for the oncology community, as it allows for broader molecular profiling and more precise treatment options. By partnering with pharmaceutical companies like Bayer and Lilly, Illumina aims to advance cancer diagnostics and improve patient outcomes. The TSO Comprehensive test is also designed to maximize the likelihood of finding actionable biomarkers from patient biopsies, providing a critical tool in the fight against cancer. Additionally, the test's approval makes it eligible for reimbursement under the Centers for Medicare & Medicaid Service national coverage determination.
Illumina is committed to expanding its pipeline of CDx claims through ongoing partnerships with pharmaceutical companies, aiming to unlock new targeted therapies and immunotherapies for cancer patients. A CE-marked version of the TSO Comprehensive test has already been available in Europe since 2022, and the FDA-approved version will begin shipping in the U.S. this year, further broadening access to precision oncology.
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