Clinical OMICS

JUL-AUG 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 July/August 2019 Clinical OMICs 35 B est known for its top-tier next-generation sequencing (NGS) instruments, Illumina won additional market attention for its companion diagnostics in January, when it received the FDA's Breakthrough Device designation for its developmental-phase pan-cancer assay, to be marketed as TruSight Oncology Comprehensive. The assay is based on Illumina's TruSight Oncology 500 (TSO 500) test, an NGS tumor profiling assay designed for detection and analysis of known and emerging solid tumor biomarkers. Launched in October 2018, TruSight Oncology 500 uses both DNA and RNA from subject tumor samples to identify key somatic variants underlying tumor progres- sion, such as small DNA variants, fusions, and splice vari- ants. TruSight Oncology 500 can measure tumor mutational burden (TMB) and microsatellite instability (MSI), target- ing 523 genes for SNV and indel detection and 55 genes for fusion and splice variant detection. "As we move to bring a future in vitro diagnostic ver- sion through regulatory approval, we will be able to set the standard for accurate and reproducible testing," said Garret Hampton, executive vice president of Clinical Genomics at Illumina. "Today's value in the capability to call for TMB is in line with current research and emerging guidelines, but the promise that TruSight Oncology 500 holds for the future identification of biomarkers makes it a robust solution for this rapidly evolving field." Illumina says it is committed to bringing the power of NGS to clinical diagnostics, delivering CDx solutions to its pharmaceutical partners and clinical testing labs by build- ing on the status of the Illumina MiSeqDx System as the first FDA-regulated and CE-IVD-marked NGS instrument for use in in vitro diagnostic procedures. "By focusing on our most differentiated oncology prod- ucts, we can meet the needs of our customers and provide a comprehensive NGS panel that includes all of the known and anticipated biomarkers associated with targeted and immune-based therapies," Hampton added. NINA GREEN VP and GM, Companion Diagnostics GARRETT HAMPTON Executive Vice President A gilent Technologies added to its 20-year history of success in companion diagnostics, starting with Her- cepTest launched in 1998, when the company received FDA approval on June 10 for expanded use of its PD-L1 IHC 22C3 pharmDx assay to identify patients with head and neck squamous cell carcinoma (HNSCC) for treatment with Merck & Co. programmed death 1 (PD-1) immunotherapy, Keytruda (pembrolizumab). Two months earlier, on April 16, the FDA approved the assay to identify a broader range of patients with stage III or metastatic non-small cell lung cancer (NSCLC) for first-line treatment with Keytruda. Agilent's PD-L1 IHC 22C3 pharmDx along with PD-L1 IHC 28-8 pharmDx, indicated for use with Bristol Meyer Squibb's immunotherapy, Opdivo (nivolumab), are approved for multiple tumor indications and hold 85+ global product registrations, according to Nina Green, vice president and GM of the Companion Diagnostics Division at Agilent Technologies. These assays are used to identify patients more likely to respond to immunotherapies, or to determine PD-L1 status to inform physicians considering treatment options for cancer patients. "Understanding what it takes to bring a companion diag- nostic assay successfully to market, Agilent is innovative, collaborative, and nimble, which ensures we constantly stay aligned with our pharma partners and their evolving requirements through the entire process: development, regulatory, manufacturing, and commercialization," Green said. "Agilent's solid reputation for high-quality, world- class products and service make us uniquely suited to part- ner with pharma for companion diagnostics." A full-service provider to pathology labs worldwide, Agi- lent's portfolio consists of instrumentation, reagents, and software. Agilent's large commercial channel and instru- ment footprint enable the company to secure access to key labs and clinicians. "Agilent also has solutions and expertise across multiple modalities spanning genomics, proteomics, and metabolomics, which provides significant capacity for growth and support of future companion diagnostics part- nerships," added Simon Oestergaard, GM and vice presi- dent of Agilent's Pathology Division.

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