Groundbreaking DNA Test Evaluates Biomarkers in 517 Cancer-Relevant Genes across 30 Types of Solid Tumors

Conventional tests for profiling biomarkers from tumor samples, 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. Now, a single in vitro diagnostic (IVD) diagnostic test can help inform therapy decisions according to clinical guidelines to enable precision medicine decisions for cancer patients.

Illumina Inc. (San Diego, CA, USA) has launched 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 IVD kit will help inform precision medicine decisions for cancer patients across the continent. This new 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.

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.

TSO Comprehensive (EU) is the first CE (Conformité Européenne)-marked IVD kit for CGP based on DNA and RNA content, having met important European standards for quality and efficacy. 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.

Illumina has a growing pipeline of companion diagnostics (CDx) claims under development, through partnerships with pharma companies, which will be added to TSO Comprehensive (EU) over time following regulatory approval. These CDx solutions will help unlock groundbreaking targeted therapies and immunotherapies to make a difference to the lives of cancer patients.

"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," said Kevin Keegan, General Manager for Oncology at Illumina. "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."

"Clinicians are increasingly matching the genetics of a patient's cancer with their therapy," explained 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."

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