Original from: Illumina

"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. "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."

A CDx test may identify whether a patient's tumor has a specific gene change or biomarker that can be targeted by a therapy, helping to determine if a patient should receive the therapy. Most CDx tests are specific to one type of cancer, but TSO Comprehensive is approved for use across solid tumor indications for the NTRK CDx, helping to maximize the chances of finding actionable information from each patient's biopsy.

NTRK gene fusions are rare across most solid cancer tumor types (~0.1%–0.3%), and can be challenging to detect, given that these genes can fuse with different partners, many of which were previously unknown. TSO Comprehensive also interrogates RNA and thus can identify a broad range of known and novel gene fusion partners across all three NTRK gene fusions, NTRK1, NTRK2, and NTRK3.  Bayer's VITRAKVI (larotrectinib) is a highly selective TRK inhibitor approved for use in patients with TRK fusion cancer, in accordance with therapeutic labeling.

NSCLC is one of the most common types of lung cancer and the leading cause of cancer-related deaths globally. The expansive actionable biomarker landscape in NSCLC has driven the need for broad molecular profiling to enable a complete view of a patient's disease to better guide clinical management. The oncogenic activation of RET fusion-positive NSCLC by gene fusions is a primary driver in NSCLC, occurring in up to 2% of cases. Lilly's RETEVMO (selpercatinib) is a highly selective and potent RET kinase inhibitor in locally advanced or metastatic NSCLC. TSO Comprehensive enables broad characterization and simultaneous detection of multiple prognostic and predictive biomarkers such as RET, genomic signatures such as tumor mutational burden, and emerging biomarkers within NSCLC in a single test.

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

TSO Comprehensive will begin shipping to customers this year. Comprehensive genomic profiling assays with CDx claims for solid tumors, like TSO Comprehensive, are reimbursable under a Centers for Medicare & Medicaid Service national coverage determination.

Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of patients with cancer.

Source: FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies