NEW YORK – Illumina said on Tuesday that it has received CE-IVD marking for its TruSight Oncology Comprehensive (EU) assay this month.
The new in vitro diagnostic kit for comprehensive genomic profiling covers a range of mutations and biomarkers associated with European Society for Medical Oncology guidelines, drug labels, and clinical trials.
Specifically, the next-generation sequencing-based assay, announced in January, detects variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin-embedded tumor tissue samples of solid malignant neoplasms and runs on the Illumina NextSeq 550 Dx.
The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, deletions, and gene amplifications from DNA, as well as gene fusions and splice variants from RNA. It also reports a tumor mutational burden score and microsatellite instability status.
"The CE-mark is a prerequisite for reimbursement of diagnostic tests by health authorities, and in some European countries, is required before laboratories can use a new testing method," Illumina said in a statement. "As a validated, CE-marked IVD, and a kitted solution, the introduction of TSO Comprehensive (EU) provides a streamlined process for use in house by any pathology lab, so that testing can be offered closer to patient care."
Illumina added that it has a a growing pipeline of companion diagnostic claims under development, which it plans to add to TSO Comprehensive (EU) over time and following regulatory approval.
The firm is also pursuing regulatory approval for a version of the assay in the US.