Clinical OMICS

MAR-APR 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com March/April 2019 Clinical OMICs 39 ANNIVERSARY ISSUE W uXi NextCODE has grown over four years into a global genomic data and insights company that powers drug and diagnostic development with biopharma and medical center partners. The company also partners with pediatric hospitals to provide clinical exome diag- nostic and interpretation services. It took its present form in 2015 when NextCODE Health was acquired by WuXi PharmaTech for $65 million. NextCODE—a spinout of per- sonalized medicine pio- neer deCODE Genetics, acquired by Amgen in 2012—was merged with WuXi's Genome Center to form the company. "WuXi NextCODE's suc- cess stems from continued innovation building on the legacies of the three com- panies from which it was formed," said Jeff Gulcher, CSO and co-founder. The first is deCODE, which generated whole genome sequence data and detailed medical data on more than 400,000 people in Iceland, and developed the database archi- tecture and tools to manage and analyze these data. The sec- ond is WuXi Apptec, which owns the only large CLIA- and CAP-accredited genomics laboratory in China. The third is new subsidiary Genomics Medicine Ireland (GMI). In November, the company joined GMI and The Ireland Strate- gic Investment Fund in a $400 million initiative intended to position Ireland as a key hub for genomics R&D. The Irish initiative broadens WuXi NextCODE's global focus; it bases operations in Shanghai; Cambridge, MA; and Reykjavik, Iceland. Also last year, WuXi NextCODE joined with Google Cloud and AWS to provide genomics services worldwide. WuXi NextCODE technologies include the SeqPlus formalin-fixed, paraffin-embedded (FFPE) sample preparation method, designed to extract DNA fragments of higher molecular weight, producing sequence align- ments that cover 98% of the genome, at a depth of 20X. That approaches results obtained with fresh frozen samples at comparable levels of sequencing, with similar numbers of heterozygous and homozygous calls. I n 2014, a year after its founding, Guardant Health launched its first of two successful assays for later-stage cancer. Guardant360 has been used since then by more than 6000 oncologists, over 50 biopharmaceutical compa- nies and all 27 National Comprehensive Cancer Network (NCCN) Centers. Guardant launched the second later-stage cancer assay in 2017—GuardantOMNI, a panel measuring 500 genes from ctDNA. Later this year Guardant will roll out LUNAR-1 recurrence monitoring tests for cancer sur- vivors, as well as LUNAR-2 tests for early detection of the disease in asymptomatic individuals. "We believe that the key to conquering cancer is unprec- edented access to its molecular information throughout all stages of the disease, which we intend to enable by a routine blood draw, or liquid biopsy," said Guardant co-founder and CEO Helmy Eltoukhy. "The challenge with diagnos- ing and treating cancer is everything today is predicated on needing physical access to the tumor. This requires surgery, scans, etcetera. Instead, if one can pro- vide the same information through blood, we could completely change the par- adigm of treating cancer." The company's success reflects its focus on put- ting patients first, hence its heavy investment in clinical evidence gener- ation. A recent example is Guardant's February release of positive study results showing Guardant360 matched standard-of-care tissue testing in first-live, advanced non-small cell lung cancer (NSCLC). "We have over 40 Guardant360-based clinical studies that have helped drive nearly 100 peer reviewed publications and nearly 300 scientific abstracts," Eltoukhy said. "These publications have been in many high-impact journals and have increasingly provided support for use of Guardant360 in the first-line advanced cancer setting, even before tissue, for genotyping applications." Jeff Gulcher, CSO and co-founder, WuXi NextCODE Helmy Eltoukhy, CEO and co-founder, Guardant Health

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