Roadblocks preventing personalized medicine from reaching its potential.

Abstract

Biomarkers in MedicineVol. 9, No. 1 CommentaryRoadblocks preventing personalized medicine from reaching its potentialJoshua P CohenJoshua P CohenTufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA E-mail Address: joshua.cohen@tufts.eduSearch for more papers by this authorPublished Online:21 Jan 2015https://doi.org/10.2217/bmm.14.66AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: biomarkersclinical utilitypersonalized medicinereimbursementReferences1 President's Council of Advisors on Science and Technology. Priorities for personalized medicine (2008). www.whitehouse.gov Google Scholar2 US FDA. Guidance for Industry and Food and Drug Administration Staff: in vitro companion diagnostic devices (2011). www.fda.gov Google Scholar3 US FDA. Paving the way for personalized medicine: FDA's role in a new era of medical product development (2013). www.fda.gov Google Scholar4 Cohen J. Overcoming regulatory and economic challenges facing pharmacogenomics. N. Biotechnol. 29(6), 751–756 (2012).Crossref, Medline, CAS, Google Scholar5 US FDA. Table of pharmacogenomic biomarkers in drug labeling (2014). www.fda.gov Google Scholar6 Reinke T. Targeted medications: new focus on companion tests. Manag. Care 21(2), 35–38 (2012).Medline, Google Scholar7 Milne C-P, Garafalo S, Bryan C et al. Trial watch: Personalized medicines in late-stage development. Nat. Rev. Drug Discov. 13, 324–325 (2014).Crossref, Medline, CAS, Google Scholar8 Cohen J, Felix A. Personalized medicine's bottleneck: diagnostic test evidence and reimbursement. J. Pers. Med. 4, 163–175 (2014).Crossref, Medline, Google Scholar9 Ansari M. The regulation of companion diagnostics: a global perspective. Ther. Innovat. Reg. Sci. 47, 405–415 (2013).Crossref, Medline, Google Scholar10 US FDA. FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer (2011). www.fda.gov Google Scholar11 Centers for Medicare and Medicaid Services. Pharmacogenomic testing to predict warfarin responsiveness. www.cms.gov Google Scholar12 Eisenberg A. Variations on a gene, and tools to find them. New York Times 27 April 2013.Google Scholar13 Tunis S, Pearson S. Coverage options for promising technologies: Medicare's ‘coverage with evidence development’. Health Aff. 25(5), 1218–1230 (2006).Crossref, Medline, Google Scholar14 NIH. Reimbursement models to promote evidence generation and innovation for genomic tests (2012). www.genome.gov Google Scholar15 Twachtman G. With personalized medicine, payers want a role in early development. The Pink Sheet (2013). www.pharmamedtechbi.comGoogle Scholar16 Edlin M. Drug manufacturers seek payer feedback. Managed Care Executive (2013). http://managedhealthcareexecutive.modernmedicine.comlGoogle Scholar17 Palmetto's Molecular Diagnostic Services Program (MolDx) program. www.palmettogba.com Google Scholar18 Usdin S. Coding for utility. BioCentury 15 July 2013.Google Scholar19 Quinn B, Hoag F. Current issues and options: coverage and reimbursement for molecular diagnostics: Department of Health and Human Services (HHS) ASPE Workgroup (2011). http://aspe.hhs.govGoogle ScholarFiguresReferencesRelatedDetailsCited ByFundamentally low reproducibility in molecular genetic cancer research30 July 2016 | Russian Journal of Genetics, Vol. 52, No. 7Companion diagnostics at the intersection of personalized medicine and healthcare deliveryScott A Waldman & Andre Terzic21 January 2015 | Biomarkers in Medicine, Vol. 9, No. 1 Vol. 9, No. 1 Follow us on social media for the latest updates Metrics Downloaded 81 times History Published online 21 January 2015 Published in print January 2015 Information© Future Medicine LtdKeywordsbiomarkersclinical utilitypersonalized medicinereimbursementFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download