US-based genome sequencing firm Illumina has rolled out a new cancer test in Europe, for scanning of multiple tumour genes and biomarkers to generate a specific genomic profile.

TruSight Oncology (TSO) Comprehensive (EU) is an in-vitro diagnostic (IVD) test that supports precision therapy decisions for cancer patients.

The comprehensive genomic profiling (CGP) test covers a wide range of mutations and biomarkers, related to European guidelines, drug labels and clinical trials, said the company.

It is designed to scan biomarkers in 517 cancer-relevant genes across nearly 30 solid tumour types by evaluating both DNA and RNA, and complex genomic signatures.

The test leverages targeted next generation sequencing (NGS) of nucleic acids extracted from cancer patients, and runs on Illumina NextSeq 550Dx instrument.

It detects single nucleotide variants, multi-nucleotide variants, insertions, deletions and gene amplifications from DNA, and gene fusions and splice variants from RNA.

In addition, the test is also capable of reporting a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status.

Illumina oncology general manager Kevin Keegan said: “This groundbreaking and 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 tumor 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.”

The comprehensive assessment using its TSO Comprehensive (EU) eliminates the need for running separate, sequential gene tests from multiple biopsy procedures.

It is the first IVD test kit for CGP based on DNA and RNA analysis to receive CE-mark approval, meaning that it has met critical European quality standards, said the company.

TSO Comprehensive (EU) is developed for  in-house use by pathology labs to ensure that testing can be offered closer to patient care.

Illumina noted that the test is intended to provide tumour profiling information for use by healthcare professionals, and is not conclusive or prescriptive for labelled use.

Illumina chief medical officer Phil Febbo said: “Clinicians are increasingly matching the genetics of a patient’s cancer with their therapy.

“When a medical center internalizes comprehensive genomic profiling of cancer, the multidisciplinary team includes a molecular pathologist who has more control over the biopsy sample and data generated, and can increase the number of informed cases they are able to deliver.

“Evidence suggests when this happens, more patients have access to CGP and precision medicine earlier on in their disease journey.”