The new CDx pan-cancer indication will allow the identification of cancer patients with solid tumours that have neurotrophic tyrosine receptor kinase (NTRK) gene fusions
Illumina adds new CDx indication to its in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test. (Credit: PRNewswire/Illumina, Inc.)
US-based biotechnology company Illumina has added a new companion diagnostic (CDx) indication to its in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test.
TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test that uses a single biopsy material to integrate less common indicators with more common ones in the same test.
Recently launched in Europe, the single test kit can analyse multiple tumour genes and biomarkers to reveal the specific molecular profile of a patient’s cancer.
The new CDx pan-cancer indication will allow the identification of cancer patients with solid tumours that have neurotrophic tyrosine receptor kinase (NTRK) gene fusions, including NTRK1, NTRK2 or NTRK3.
The firm said that the addition of this first CDx claim for NTRK gene fusions aids patients with this genetic change in receiving larotrectinib, a genomically matched medication.
Illumina senior vice president and Europe, the Middle East, and Africa general manager Paula Dowdy said: “This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina’s broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine.
“We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don’t want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy.”
Analytical and clinical validation tests were used to evaluate the performance of TSO Comprehensive (EU) with NTRK fusions, said the company.
The clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2, and NTRK3 gene fusion-positive patients were demonstrated using the data from three clinical trials: LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431), and SCOUT (NCT02637687).
In March this year, the company launched the TruSight Oncology (TSO) Comprehensive (EU) test in Europe.