CAMBRIDGE, Mass. and SHANGHAI, March 30, 2019 /PRNewswire/ — WuXi NextCODE, a global genomic data and insights company, 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 WuXi NextCODE’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 WuXi NextCODE. “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.”
As the first CAP/CLIA/ISO 15189 certified laboratory in China, the company’s Shanghai laboratory already offers comprehensive next generation sequencing (NGS) clinical and discovery research services. WuXi NextCODE has also recently acquired a large scale NGS laboratory in Dublin, Ireland, which is already CAP-accredited and anticipated to be CLIA-certified in the third quarter of 2019.
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 WuXi NextCODE’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 WuXi NextCODE 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 WuXi NextCODE. “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.”
About WuXi NextCODE
WuXi NextCODE is a global genomic data and insights company with operations in Kendall Square, Cambridge, Massachusetts, and in Dublin, Reykjavik and Shanghai. We serve the world’s leading life sciences companies including biotechnology, pharmaceutical companies and medical research centers. Our partners all use insights from genomic data to improve health. Our capabilities include providing access to population-scale patient cohorts for research, next generation sequencing (NGS) CLIA/CAP GCP labs globally, and a team of the world’s leading A.I. and genomic analysis experts and technologies for organizing, mining and sharing genomic and disease biology data. Visit us on the web at wuxinextcode.com.