The new in-vitro diagnostic (IVD) kit also assesses biomarkers to produce a specific molecular profile of a patient’s cancer.
This helps to inform precision therapy decisions for cancer patients.
The TSO Comprehensive (EU) test kit covers a wide range of mutations, as well as biomarkers related to the European Society for Medical Oncology guidelines, drug labels and clinical trials.
Illumina Oncology general manager Kevin Keegan said: “The accurate diagnostic kit provides information clinicians can use to help match their patients to available therapies according to clinical guidelines or clinical trials, based on their tumour profile.
“At Illumina, we are proud to be bringing innovations like this to market, and to be at the forefront of unlocking the power of the genome for human benefit.”
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The company said that by assessing RNA and DNA, as well as complex genomic signatures, the new CGP test can evaluate biomarkers in 517 cancer-relevant genes across approximately 30 types of solid tumours.
It can also assess Microsatellite Instability (MSI) status and Tumor Mutational Burden (TMB) score.
The IVD test runs on the Illumina NextSeq 550Dx instrument and uses targeted next-generation sequencing to identify variants in 517 genes from nucleic acids extracted from formalin-fixed, paraffin-embedded (FFPE) tumour tissue samples of cancer patients.
It can be used to detect multi-nucleotide variants, insertions, single nucleotide variants, deletions and gene amplifications from DNA, along with gene fusions and splice variants from RNA.
With this assessment, the need to run separate, sequential gene tests from several biopsy procedures can be avoided.
The test is claimed to be the first IVD test kit for CGP based on DNA and RNA content to receive CE-mark.