Clinical OMICS

JAN-FEB 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 January/February 2019 Clinical OMICs 3 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 JULIANNA LEMIEUX, PH.D. Senior News Editor ALEX PHILIPPIDIS Chief Copy Editor STEVEN HERNACKI Contributing Editors CHRISTINA BENNETT, CAMILLE MOJICA REY, PH.D. Art Director JAMES LAMBO Online Product Manager SEAN HELMES Associate Director of Brand Marketing JENNIFER GATTI Online Editorial Supervisor KATHERINE VUKSANAJ Design & Layout DIANNE PAULET, BYRON DUQUE Advertising Sales Manager KAYLA MCCUTCHAN US West & Asia Pacific (kmccutchan@clinicalOMICs.com / 510-619-6988) Advertising Sales Manager REBECCA SHUMBATA US East, UK, & Europe (rshumbata@clinicalOMICs.com/ 617-435-4786) List Sales SCOTT PERILLO (sperillo@ClinicalOMICs.com / 914-740-2178) Sales Administrator FALLON MURPHY Advertising Material WANDA SANCHEZ (wsanchez@liebertpub.com) 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. 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: www.clinicalomics.com Copyright © 2019 by GEN Publishing, New Rochelle, NY T his month, our feature on companion diagnostics focuses on the challenges they face in reimbursement, and undercutting by laboratory developed tests (LDTs). With so much attention on precision medicine, the struggles faced by CDXes—tests that actually deliver on the promise of more precise treatments for patients—should give us all pause. Outside the machinations of CDxes getting appropriate pay- ments and market protection, Jona- than Lancaster, M.D., chief medical officer of Myriad Genetics believes there are other, broader forces that may ultimately affect the implemen- tation of precision medicine. Lancaster, is a gynecologic oncologist by training who spent 13 years at the Moffitt Cancer Center running its precision medicine discovery lab before join- ing Myriad. He considers himself an optimist, noting he has "spent thousands of hours writing grants to NIH to support my molecular genetics lab" and the work it was doing to further precision medicine. But Lancaster thinks we are at an inflection point of whether precision med- icine can fully take root. "Precision medicine—or biomarkers, or companion diagnostics—are tools by which we identify which patients can receive drugs. So they are patients receiv- ing a drug they wouldn't have absent a biomarker —and that is true for only a percentage of the patients" he explained. "But there is a double click there that is worthy of discussion, and it is that, by definition, this also means identifying a cohort of patients who should not receive that drug because the likelihood of benefit is small or absent." The struggle for doctors in this situation is real, Lancaster said. "We like to say we engage in precision medicine. We run these tests so my patients get drugs that they might not have had. It is a very different discussion to say that also means some of my patients are not going to have a drug that I might oth- erwise have given." The change required to practice precision medicine in the way that will be of most benefit is a philosophical challenge for doctors, who now must become comfortable telling patients they can't receive a specific drug based on their test results. If doctors get test results indicating a drug should be withheld, but aren't comfortable with this and prescribe the drug anyway, then the benefit disappears. "If we don't embrace this, we are going to go bankrupt," Lancaster con- cluded. "If we don't take advantage of it and keep giving the drug to everyone because we say we want to do precision medicine, but we don't withhold drug, then the system is not sustainable." FROM THE EDITOR Chris Anderson Editor in Chief Are We Ready for Precision Medicine?

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