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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10 Clinical OMICs May/Junel 2018 Publisher & CEO MARY ANN LIEBERT President MARIANNE RUSSELL Group Publisher SANDE GIACCONE Editor in Chief CHRIS ANDERSON EVP, Strategic Development KEVIN DAVIES Commercial Director BILL LEVINE Production Editor ROBERT M. REIS Senior Editor KEVIN MAYER Technical Editor JEFFREY S. BUGULISKIS, PH.D. Senior News Editor ALEX PHILIPPIDIS Chief Copy Editor STEVEN HERNACKI Contributing Editors DIANA MANOS, CAMILLE MOJICA REY, VICKI GLASER Art Director JAMES LAMBO Online Product Manager THOMAS MATHEW Associate Director of Brand Marketing JENNIFER GATTI Online Editorial Supervisor KATHERINE VUKSANAJ Design & Layout DIANNE PAULET, BYRON DUQUE Advertising Sales Manager REBECCA SHUMBATA US West & Asia Pacific ( / 617-435-4786) Advertising Sales Manager STAN KASHINE US East, UK, & Europe ( / 516-626-2813) List Sales SCOTT PERILLO ( / 914-740-2178) Sales Administrator FALLON MURPHY Advertising Material WANDA SANCHEZ ( Clinical OMICs Advisory Board DANIEL H. FARKAS, PH.D., HCLD Section Head, Molecular Pathology, Cleveland Clinic JEFFREY GIBBS, J.D. Director, Hyman, Phelps, and McNamara PETER HARRSCH, PH.D. Executive Clinical/Forensic Specialist, Waters Corp. ROGER KLEIN, M.D., J.D. Principal, Roger D. Klein, MD JD Consulting JASON PARK, M.D., PH.D. Assistant Professor, Dept. of Pathology, University of Texas Southwestern Medical Center STEPHEN C. PEIPER, M.D. Professor & Chair, Dept. of Pathology, Anatomy & Cell Biology, Thomas Jefferson University AMIT RASTOGI Senior Vice President, Strategy, Growth, and Innovation, Inova DAVID SMITH, PH.D. Professor of Laboratory Medicine and Pathology, Mayo Clinic KIMBERLY STRONG, PH.D. Director, Program in Genomics and Ethics, Medical College of Wisconsin LARRY WORDEN Principal, IVD Logix The views, opinions, findings, conclusions, and recommenda- tions set forth in any article in Clinical OMICs are solely those of the authors of those articles and do not necessarily reflect the views, policy, or position of Clinical OMICs, its Publisher, or its editorial staff and should not be attributed to any of them. All advertisements are subject to review by the Publisher. The acceptance of advertisements does not constitute an endorse- ment of the product or service advertised. Clinical OMICs (ISSN-2334-1351) is published online bimonthly by GEN Publishing, 140 Huguenot St., 3rd Floor, New Rochelle, NY 10801-5215. For subscription information go to: Copyright © 2018 by GEN Publishing, New Rochelle, NY FROM THE EDITOR Chris Anderson Editor in Chief R ecent research published from the MedSeq Project, which is examining the effects on health costs and health outcomes, has shown encouraging results that suggests providing these tests to both healthy people and to car- diology patients may not increase downstream costs and healthcare utiliza- tion—at least in the six-month window data was available for these cohorts. But let's not kid ourselves into thinking that the broad use of whole-ge- nome, or whole-exome sequenc- ing for all patients is right around the corner. There simply is no indication that healthcare sys- tems, or individual doctors and other health providers are ready or equipped to make meaningful use of these data to guide health and wellness decisions. There are a number of hurdles standing in the way of this broad applica- tion of genomic medicine. First is the issue of data integration with electronic medical records. It's no secret EMR vendors' systems are not good at data integration. HL7 efforts to encourage adoption of the FHIR data standard may help solve this problem to an extent, but then there is an additional problem: EMRs were primarily designed to help with insurance coding, not as a comprehensive picture of a patient's health. Both need significant work to accommodate genomic data. Second, most health systems, hospitals and care providers are not up to speed on what might be actionable information in a patient's genome, or even whether a variant that indicates an elevated risk of a specific disease is worth addressing. The folks at the National Association of Genetic Counsel- ors will say this is an appropriate role for their members, and they'd be right, but there just aren't enough genetic counselors in this country to handle such broad use of genomics in healthcare. And finally, there is the question of who will pay for the testing. The Med- Seq Project cited sequencing costs of $5,000 per genome. Granted, the cost of whole-genome sequencing has decreased since the time of the tests in this pilot study. But despite a broad belief this would be a one-time cost that could pay dividends for a lifetime, no payers in this country, public or private, are showing any willingness to take on this cost without more proof of value. Which is exactly why projects like MedSeq, or the work at health systems like Sanford in North Dakota and Geisinger in Pennsylvania, or the 100,000 Genomes Project in the U.K.—which has a stated goal of applying genomics within the NHS—are so vital. MedSeq measured downstream costs for six months and have consented many in the study to be followed for five years. Now, BabySeq will begin tracking and measuring the value of providing sequencing from the very beginning of life. It's data from these sources that will help advance genomics as normal and routine in healthcare. The time is coming. It's just not time yet. Is it Time to Sequence Everyone's Genome? Not yet.

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