Illumina announced the launch of TruSight Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer.
With its global launch first taking place in Europe, the in vitro diagnostic (IVD) kit will help inform precision medicine decisions for cancer patients across the continent.
This new in vitro diagnostic (IVD) comprehensive genomic profiling (CGP) kit covers a broad range of mutations and current and emerging biomarkers associated with the European Society for Medical Oncology guidelines, drug labels and clinical trials, maximizing the chances of finding actionable information from each patient's biopsy.
Conventional tests, such as single biomarker tests and targeted hotspot panels, are limited in the number of targets they analyze which increases the chances of missing critical information.
TSO Comprehensive (EU) assesses biomarkers in 517 cancer-relevant genes across nearly 30 solid tumor types by evaluating both DNA and RNA, and complex genomic signatures, such as microsatellite instability (MSI) and tumor mutational burden (TMB).
This comprehensive assessment eliminates the need for running separate, sequential gene tests from multiple biopsy procedures. The fast turnaround time of four to five days for sample-to-clinical report generation, versus weeks in some cases, enables clinicians to make decisions regarding personalized medicine or clinical trial enrollment for their cancer patients.
"The most pressing challenge we face in profiling biomarkers from tumor samples is the ability to keep up with the pace of new biomarkers linked to new therapies and clinical trials," says Rhian White, Consultant Clinical Scientist at the All Wales Medical Genomics Services, Cardiff, UK.
"We need a testing platform that can assess all these biomarkers, while at the same time preserving limited biopsy specimen. Comprehensive genomic profiling has proven to be this platform."
The CE-mark is a pre-requisite for reimbursement of diagnostic tests by health authorities, and in some European countries, is required before laboratories can use a new testing method. 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.
"Clinicians are increasingly matching the genetics of a patient's cancer with their therapy," explains Phil Febbo, MD, Chief Medical Officer at Illumina.
"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."
The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, deletions and gene amplifications from DNA, and gene fusions and splice variants from RNA. The test also reports a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status. ■