Illumina (Nasdaq:ILMN) announced today that it launched its TruSight oncology test for assessing multiple tumor genes and biomarkers.
San Diego-based Illumina’s CE-marked TruSight test, which will begin its global launch in Europe, assesses the tumor genes and biomarkers to reveal the specific molecular profile of a patient’s cancer, helping to inform precision medicine decisions.
According to a news release, the new in vitro diagnostic (IVD) complete genome profiling (CGP) kit covers a wide array of current and emerging mutations and biomarkers, maximizing the chances of finding actionable biopsy information for each patient.
Illumina said TruSight assesses biomarkers in 517 cancer-relevant genes in nearly 30 solid tumor types by evaluating both DNA and RNA, along with complex genomic signatures like microsatellite instability (MSI) and tumor mutational burden (TMB). It aims to eliminate the need for separate sequential genetic testing from multiple biopsy procedures, leading to a rapid turnaround time of four to five days for sample-to-clinician reporting, compared to weeks in some cases.
“This innovative and accurate diagnostic kit provides information that clinicians can use to help their patients find available therapies based on clinical guidelines or clinical trials, based on their tumor profile,” Illumina GM of Oncology Kevin Keegan said in the release. “At Illumina, we are proud to bring innovations like this to market and to be at the forefront of unlocking the power of the genome for human benefit.”
Illumina said that its TruSight oncology test is the first IVD kit for PGC with CE mark based on DNA and RNA content.
“Doctors are increasingly matching a patient’s cancer genetics to their therapy,” Illumina CMO Dr. Phil Febbo said. “When a medical center internalizes comprehensive cancer genomic profiling, the multidisciplinary team includes a molecular pathologist who has more control over the biopsy sample and the data generated, and can increase the number of reported cases they can deliver.
“Evidence suggests that when this happens, more patients have access to PGC and precision medicine earlier in their disease process.”