Illumina, Inc. (NASDAQ: ILMN) has secured the FDA's approval for its in vitro diagnostic (IVD) TruSight Oncology Comprehensive test and first two companion diagnostic (CDx) indications. The test analyses more than 500 genes to profile a patient's solid tumor, improving the chances of identifying an immuno-oncology or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment.
The latest development marks a long-awaited milestone for the company's oncology customers and community. In Europe, a separate CE-marked version of TSO Comprehensive has been available since its launch in 2022.
Role of ILMN's TSO Comprehensive Test as a CDx
A CDx test can reveal 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 treatment. Illumina's TSO Comprehensive is FDA-approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer's VITRAKVI (larotrectinib). VITRAKVI is a highly selective TRK inhibitor approved for use in patients with TRK fusion cancer, in accordance with therapeutic labeling.
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 interrogates ribonucleic acid and can identify a broad range of known and novel gene fusion partners across all three NTRK gene fusions, NTRK1, NTRK2 and NTRK3.
Most CDx tests are specific to one type of cancer, however, TSO Comprehensive is approved for use across solid tumor indications for the NTRK CDx. This helps to maximize the chances of finding actionable information from each patient's biopsy.
Importance of ILMN's TSO Comprehensive in NSCLC Treatment
The test is also approved to identify adult patients with locally advanced ...
