FDA Approves Illumina’s TruSight Oncology Comprehensive Test for Pan-Cancer Companion Diagnostics

FDA Approval:
The FDA has approved Illumina's TruSight Oncology Comprehensive test, a 500+ gene biomarker test for solid tumors, as a pan-cancer companion diagnostic.

Companion Diagnostics: The test is approved for two companion diagnostic indications:

Identifying patients with NTRK gene fusions for treatment with Bayer's VITRAKVI (larotrectinib).
Detecting RET fusion-positive non-small-cell lung cancer (NSCLC) patients for treatment with Lilly's RETEVMO (selpercatinib).

Comprehensive Genomic Profiling:
The test interrogates over 500 genes to profile a patient's solid tumor, increasing the likelihood of identifying actionable biomarkers for targeted therapy options or clinical trial enrollment.

Pan-Cancer Approach:
TSO Comprehensive is approved for use across solid tumor indications for the NTRK CDx, maximizing the chances of finding actionable information from each patient's biopsy.

Market Impact:
The approval represents a significant market opportunity for Illumina, positioning the company to capture a larger share of the oncology diagnostics market and potentially driving long-term growth as more targeted therapies enter the market.