The addition of the new diagnostic to the CE-marked comprehensive genomic profiling (CGP) test is intended to match cancer patients with rare genetic mutations to targeted treatments.
Recently launched across Europe, the single test kit can reveal the specific molecular profile of a patient’s cancer by assessing multiple tumour genes and biomarkers.
The CDx indication will help identify cancer patients with solid tumours positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions, including NTRK1, NTRK2 or NTRK3.
These patients may benefit from targeted therapy with Bayer ‘s genomically matched treatment, VITRAKVI (larotrectinib).
The in vitro diagnostic TSO Comprehensive (EU) test uses a single biopsy specimen to combine less prevalent biomarkers with those that are more prevalent.
The combination helps increase the chances of finding actionable information from each patient’s biopsy, which would then enable treatment with targeted therapies.
Based on their unique tumour genomic profile, patients could also be enrolled in clinical trials.
The addition of the first diagnostic claim specific to NTRK gene fusions helps provide an opportunity for patients harbouring this genetic alteration to benefit from larotrectinib.
Illumina Europe , Middle East and Africa senior vice-president and 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.”
In March, Illumina launched the TruSight Oncology test for the evaluation of multiple tumour genes in Europe.