TruSight Oncology Test Receives FDA Approval for NTRK and RET Fusion Cancers

• The TruSight Oncology (TSO) Comprehensive test has received approval from the FDA as a companion diagnostic (CDx) for 2 important cancer indications.
• The test is approved to identify patients with solid tumors harboring NTRK gene fusions and non–small cell lung cancer (NSCLC) harboring RET gene fusions.
• This marks the first distributable comprehensive genomic profiling in vitro diagnostic kit with pancancer companion diagnostic claims to be approved by the FDA.

The FDA has granted approval of the TSO Comprehensive test and its first 2 companion diagnostic (CDx) cancer indications.¹ This approval makes it the first comprehensive genomic profiling in vitro diagnostic kit with pancancer claims to receive FDA clearance.

Now, this test is indicated to identify adult and pediatric patients with solid tumors that harbor NTRK gene fusions. These patients may be eligible for treatment with the targeted therapy larotrectinib (Vitrakvi). This agent has shown promising results in clinical trials for patients with NTRK-fusion positive cancers.

DNA molecule : © ktsdesign - stock.adobe.com

The TSO test is also approved to identify adult patients with locally advanced or metastatic NSCLC that harbor RET gene fusions. These patients may be eligible for treatment with selpercatinib (Retevmo), another targeted therapy that is specifically designed for patients with RET fusions or mutations.

"FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community," said Everett Cunningham, chief commercial officer of Illumina, in a press release. "We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients."

The TSO test is a next-generation sequencing-based assay that provides comprehensive genomic profiling of solid tumors. The test interrogates over 500 genes, including genes that are commonly associated with cancer driver mutations, fusions, and copy number variations. Additionally, the test can be utilized to identify biomarkers that may be relevant for targeted therapy, immunotherapy, or clinical trial enrollment.²

By providing a more complete picture of a patient’s tumor biology, the TSO test can help to increase the likelihood of identifying targeted therapy options or clinical trial opportunities.

REFERENCES:

1. FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies. News release. Illumina, Inc. August 27, 2024. Accessed August 27, 2024. https://tinyurl.com/36b3cxtm

2. Products. Illumina, Inc. Accessed August 27, 2024. https://tinyurl.com/yhkphehw