TEST:

TruSight Oncology Comprehensive (EU)

Conclusion Clinical efficacy of larotrectinib for the TSO Comp NTRK fusion positive population (97 patients, ORR=78.4%, 95% CI [69%, 86%]) was similar to the efficacy of larotrectinib in the total extended primary efficacy analysis population (164 patients, ORR=73%, 95%CI [65%, 79%]). Study results support the use of the TSO Comp (EU) assay to aid clinicians in identifying cancer patients with NTRK gene fusions who may be eligible for treatment with larotrectinib.

A high proportion of tumors with locally identified NTRK gene fusions were confirmed centrally. At present, analysis of ctDNA is significantly less sensitive at detecting NTRK gene fusions. A negative ctDNA result requires next-generation sequencing testing of a tissue biopsy.

DNA small variant Negative Percent Agreement was 99.999% (70,000,481/70,000,907). PPA for gene amps was 92.3% (337/365), for MSI status 93% (40/43). PPA for RNA fusions and for RNA splice variants was 80.5% (70/87).

"Illumina, Inc....today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling."

"Illumina announced on Wednesday at the World CDx Summit in London that it has forged a long-term strategic collaboration with Janssen Biotech to accelerate the development of precision medicines...The collaboration aims to utilize Illumina's portfolio of resources, including AI-based genome interpretation tools, whole-genome sequencing, and multiomic analysis services, according to the company...As part of the partnership, Illumina and Janssen will codevelop CDx programs on Illumina's TruSight Oncology Comprehensive assay, a single test that assesses multiple tumor genes and biomarkers in a patient's cancer."

"Illumina...today announced the launch of TruSight™ Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. With its global launch first taking place in Europe, the in vitro diagnostic (IVD) kit will help inform precision medicine decisions for cancer patients across the continent."