Cancer cells, illustration

Illumina has added a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) test in the EU. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to provide the specific molecular profile of a patient’s cancer.

The new 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).

“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,” said Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa.

TruSight currently combines less prevalent biomarkers with more common ones in the same test, using a single biopsy specimen. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide eligible patients with an opportunity to benefit from larotrectinib, a genomically matched treatment.

The NTRK claim is pan-cancer, enabling the targeting of multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient’s biopsy, to inform treatment with larotrectinib.

“Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Bayer’s Oncology Strategic Business Unit. “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. to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions.”

The performance of TSO Comprehensive with NTRK fu­sions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of the test in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib.

“We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel,” said Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. “TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines.”

TruSight Oncology Comprehensive is an in vitro diagnostic test that uses targeted next generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument.

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