Clinical OMICS

MAY-JUN 2018

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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22 Clinical OMICs May/June 2018 www.clinicalomics.com lung cancer (NSCLC)—three biomarkers validated for selection of relevant targeted therapies (EGFR, ROS1, or BRAF), and 20 additional genes relevant for NSCLC pathogenesis, analytically validated for variant detection from NSCLC tissue. Joydeep Goswami, Ph.D., president of Clinical NGS and Oncology for Thermo Fisher, said the final NCD increased by 58% the number of U.S. lives covered for Oncomine Dx Target Test by adding CMS' 58.9 million lives. The balance of the 160 million lives covered for the test, Goswami said, is covered by commercial payers that include Cigna, Aetna, UnitedHealthcare, Independence Blue Cross, and Humana. "The potential for greater usage of Oncomine Dx Target Test is substantial given that the average age of NSCLC diagnosis in the United States is 70, with two-thirds of those diagnosed being of Medicare age," Goswami said. "Additionally, we expect this CMS decision to encourage the development of more NGS-based tests and greater adoption of these tests by labs to help patients. We are also hopeful that the FDA will continue to streamline require- ments to help these tests to get to market faster and more cost-effectively." The FDA on April 12 approved two final guidance doc- uments designed to advance NGS test development. One allows developers to rely on clinical evidence from FDA-rec- ognized public databases to support clinical claims for their tests. The other offers recommendations for designing, developing, and validating NGS-based tests, and explains what the FDA would seek in premarket submissions. Looking Toward Expansion Regulatory streamlining, Goswami added, should rap- idly expand the pool of NGS-based FDA approved tests to include liquid biopsy and immuno-oncology-based tests. In January, Thermo Fisher launched the Oncomine Pan-Cancer Cell-Free Assay for liquid biopsy analysis, and the Onco- mine Tumor Mutation Load Assay for immuno-oncology analysis. Last year, the company launched the Oncomine Immune Response Research Assay, Immune Repertoire Assay Plus, TCR beta, and Oncomine Myeloid Research Assay. Oncomine Dx Target Test is designed for marketing overseas—it expects to launch the test in Europe and parts of Asia in the second half of 2018—and to eventually incorporate indications beyond NSCLC. Some of the 46 genes on the test's panel are being studied by pharmacetuical companies for drugs in their development pipelines.The company aims to develop companion diagnostics for Agios Pharmaceuticals' Phase III candidate ivosidenib (AG-120), aimed at identifying isocitrate dehydrogenase 1 (IDH1) mutations in patients with cholangiocarcinoma, and develop CDx for Blueprint Medicines' Phase I BLU-667, designed to identify RET fusions in NSCLC patients. The FDA has also granted marketing authorization to Memorial Sloan Kettering Cancer Center (MSK) for another advanced cancer NGS test. MSK-IMPACT (Inte- grated Mutation Profiling of Actionable Cancer Tar- gets) is a 468-gene panel designed to detect gene mutations and other critical genetic aberrations in rare and common cancers. In November, MSK-IMPACT became the first tumor-pro- filing laboratory-developed test (LDT) to win FDA approval. The single-site assay, performed at MSK, (continued from previous page) (continued on page 24) Laboratory workers prepare to run a diagnostic test on Thermo Fisher Scientific's Ion Torent NGS platform. Foundation Medicine's FoundationOne CDx won FDA approval and a CMS NCD late last year via the agencies' parallel review program.

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