Genuity Science (formerly known as WuXi NextCODE) is expanding its laboratory footprint into the U.S. with the opening of a state-of-the-art, CLIA-certified and CAP-accredited genetic analysis laboratory in Woburn, Massachusetts. The new laboratory is geographically close to Genuity Science’s U.S. office in Cambridge, Massachusetts.
“This new laboratory helps us provide our customers with the access to next generation sequencing for clinical trials around the world, under the roof of one single, highly respected organization,” says Rob Brainin, Chief Executive Officer of Genuity Science. “Our global lab footprint also ensures a seamless unified workflow with a single chain of custody, from sample management, standard operating procedures, rigorous implementation of quality systems, to analytics and standardized reporting, in the U.S., Asia and the E.U.”
The first oncology panel to be offered in the U.S. lab’s CLIA/CAP environment will be Illumina’s new TruSight Oncology 500™ (TSO 500), which is a comprehensive pan-cancer tumor profiling assay that can support prospective patient enrollment in clinical trials, retrospective exploratory translational research and biomarker discovery applications. The TSO 500 research use only (RUO) test provides comprehensive coverage of established and emerging oncology biomarkers with the ability to provide rapid turnaround time. The panel will initially be offered at Genuity Science’s newly opened U.S. laboratory and then launched across the company’s other global laboratories in Shanghai and Dublin.
TSO 500’s comprehensive, integrated next-generation sequencing assay combines a DNA+RNA workflow (when bundled with the TruSight ™ Tumor 170 RNA panel) from the same FFPE tumor-only sample to accurately, reproducibly and comprehensively identify key somatic variants underlying tumor progression. These variants include DNA variants across 523 genes (including SNVs, indels and copy number abnormalities), and gene fusions and splice variants from the integrated RNA assay of 55 genes. Notably, TSO 500 also measures tumor mutational burden (TMB) and microsatellite instability (MSI), features that are potentially key response biomarkers for immune-based therapies. WuXi NextCODE’s deployment of the TSO 500 assay allows users full access to raw genomic data for further analysis and future use, in addition to robust standardized variant reporting.
“We are very pleased to supply Genuity Science with Illumina’s TruSight Oncology 500 assay to enable the company’s translational research customers,” says Garret Hampton, Ph.D., Senior Vice President of Clinical Genomics at Illumina. “We expect that the use of TruSight Oncology 500 will lead to robust biomarker discovery, while also directly supporting oncology-focused therapeutics and companion diagnostic development.”
“This assay’s comprehensive genomic footprint, speed, accuracy, sensitivity and convenience make it a true game changer in our ability to support our customers’ comprehensive oncology panel profiling needs – whether it be for patient selection or stratification in clinical development programs or for biomarker discovery,” says Richard Williams, MB BS, PhD and Managing Director and Head of Oncology at Genuity Science. “We are well prepared to help our clients navigate this sometimes-challenging road to regulatory approval for a biomarker-guided cancer treatment, and TSO 500 is central to our strategy to enable our partners to bring the next generation of cancer drugs to patients in need.”