Clinical OMICS

JAN-FEB 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 January/February 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 HELEN ALBERT, MALORYE BRANCA, MEGHAAN FERREIRA, CAMILLE MOJICA RE 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 DENIS SEGER US West & Asia Pacific ( / 760-518-5222) Advertising Sales Manager LARRY MAHER US East, UK, & Europe ( / 312-342-0849) Sales Administrator FALLON MURPHY Advertising Material WANDA SANCHEZ ( Clinical OMICs Advisory Board DANIEL H. FARKAS, PH.D., HCLD Chief Clinical Laboratory Officer, Celmatix 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. Medical Director, Molecular Pathology, Cleveland Clinic 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 Vice President and Senior Partner, Market Diagnostics International 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 D iagnostics manufacturers will tell you that one of the big challenges is predicting whether—and how much—insurers will pay for new tests developed and brought to market. To date, both labs and test makers have faced widely varying policies and payment rates from private and public insurers for the provision of molecular testing. In this is not tenable for continued advances in precision medicine, in tailor- ing treatments to each patient's unique molecular make up. But this may be changing. This issue, staff editor Alex Philippidis examines the Parallel Review Program that allowed the FoundationOne CDx test to win concurrent marketing approval from the FDA and a proposed National Coverage Decision (NCD) from CMS. This action bridges the gap between an FDA approval that a test reproduc- ibly and accurately diagnoses a disease and whether the provision of the test provides an economic benefit in determining how healthcare is delivered. It also may mark the official coming out party, if you will, of next-genera- tion sequencing as a tool for broadly reimbursed molecular testing. Accord- ing to a CMS spokesperson, should FoundationOne CDx gain a final NCD, expected early this year, four additional NGS-based tests would also qualify for coverage: Thermo Fisher Scientific's Oncomine Dx Target Test (which in December, won a similar NCD); Foundation Medicine's FoundationFocus CDxBRCA; Illumina's Praxis Extended RAS Panel; and Memorial Sloan Ket- tering Cancer Center 's MSK-IMPACT panel. There are two important developments here to note. First, the Parallel Review Program shines new light on an approval pathway that has existed in the shadows for six years and could serve as a method to bring diagnostic tools to the clinic. Second, it highlights the FDA's evolving view of NGS- based tests that portends a growing number of approvals in the coming years. That is not to say theses development were not viewed with consternation in some quarters. Notably, those who run molecular pathology labs in hos- pitals and academic medical centers worry they might lose out on getting insurance coverage for in-house laboratory-developed tests (LDTs) if reim- bursement for testing is tied directly to an FDA approval. It's yet another plot twist in the ongoing debate surrounding LDTs and one that doesn't seem to have a resolution on the horizon. But leaving aside the LDT debate, it's clear the FoundationOne approval and proposed NCD is a step in the right direction. And if the test is successful in the marketplace, the sleepy Parallel Review Program that rightly marries both clinical validity with clinical utility, can expect to get more interest from diagnostic developers. Turning the Corner on Molecular Testing Reimbursement FROM THE EDITOR Chris Anderson Editor in Chief

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