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Illumina Adds CDx Indication to European TruSight Oncology Test for NTRK Gene Fusion Detection

NEW YORK – Illumina said on Tuesday that it has added a companion diagnostic indication to its in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test.

The CDx pan-cancer indication, developed in partnership with Bayer, 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 treatment with Bayer’s Vitrakvi (larotrectinib).

Recently CE-marked and launched across Europe, TSO Comprehensive (EU) is a comprehensive genomic profiling test that uses next-generation sequencing to assess multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient’s cancer.

The performance of the test with NTRK fusions was assessed by analytical and clinical validation studies, according to Illumina, using pooled data from three clinical trials.

"Since it launched four years ago, Vitrakvi has demonstrated high response rates and highly durable responses in adults and children with [tyrosine receptor kinase] fusion cancer," said Christine Roth, a member of the executive committee of Bayer's pharmaceuticals division and head of Bayer's oncology strategic business unit, in a statement. "The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for Vitrakvi is an important advance in enabling precision oncology for patients in Europe."

Illumina also said it has “a growing pipeline” of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals.