FDA Approves TruSight Oncology Comprehensive Assay As Pan-Tumor Companion Diagnostic

The FDA has approved the TruSight Oncology (TSO) Comprehensive Assay and its first 2 indications as a companion diagnostic for distributable comprehensive genomic profiling.¹

The qualitative in vitro diagnostic (IVD) kit, developed by Illumina, is the first diagnostic kit to be FDA approved for the identification of adult and pediatric patients with NTRK-positive solid tumors who may benefit from treatment with larotrectinib (Vitrakvi), as well as adult patients with locally advanced or metastatic RET fusion–positive non–small cell lung cancer (NSCLC) who may benefit from treatment with selpercatinib (Retevmo).

“Through research conducted globally, there is a significant body of evidence demonstrating the clinical utility of comprehensive genomic profiling for patients with advanced cancer,” Vivek Subbiah, MD, chief of Early-Phase Drug Development at Sarah Cannon Research Institute in Nashville, Tennessee, added in another news release. “Illumina’s newest distributable IVD kit for comprehensive genomic profiling and accompanying companion diagnostic enable another valuable clinical tool for the oncology community to match patients with targeted therapies that can vastly improve their journey and outcomes.”

Unlike most companion diagnostic tests, which are specific to a single tumor type, the TSO Comprehensive Assay is approved across solid tumor indications. The test utilizes targeted next-generation sequencing to profile over 500 biomarkers, facilitating the detection of cancer-driving genetic alterations across various tumor types. These include single nucleotide variants, multi-nucleotide variants, DNA insertions or deletions, fusions in 24 genes, and splice variants in an RNA gene. A tumor mutational burden score is also generated with the test. This unique design enhances the likelihood of identifying clinically actionable biomarkers, thereby enabling personalized therapy recommendations and potentially supporting clinical trial enrollment based on a patient’s specific genomic profile.

In addition to its use as a companion diagnostic in NSCLC and NTRK-positive solid tumors, the TSO Comprehensive Assay can provide tumor profiling information for patients with solid malignant neoplasms in accordance with professional guidelines, supporting personalized treatment decisions.

On August 27, 2024, Illumina announced that the TSO Comprehensive Assay will begin shipping to customers in 2024 and is reimbursable under the Centers for Medicare & Medicaid Services’ national coverage determination for comprehensive genomic profiling assays with companion diagnostic claims for solid tumors. The company is actively expanding its pipeline of companion diagnostic claims for the TSO Comprehensive Assay through partnerships with pharmaceutical companies, with future claims to be added to pending regulatory approvals for the assay.

A separate CE-marked version of the TSO Comprehensive Assay has been available for use in the European Union since its launch in 2022.

Reference

FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies. News release. Illumina. August 27, 2024. Accessed September 9, 2024. https://www.illumina.com/company/news-center/press-releases/press-release-details.html?newsid=cca694db-8cc7-4b6a-9449-38ccd9329816