LEADER 00867nam0-2200313---450- 001 990008387380403321 005 20060928162730.0 035 $a000838738 035 $aFED01000838738 035 $a(Aleph)000838738FED01 035 $a000838738 100 $a20060928d1933----km-y0itay50------ba 101 0 $aita 102 $aIT 105 $aa---b---001yy 200 1 $aRoma$ecatalogo$fIstituto Nazionale LUCE 210 $aRoma$cGrafia$d1933 215 $a2 v.$cill.$d24 cm 225 1 $aArchivio fotografico nazionale$eopere d'arte, paesaggio 610 0 $aRoma$aBeni culturali 710 02$aIstituto nazionale Luce$0417603 801 0$aIT$bUNINA$gRICA$2UNIMARC 901 $aBK 912 $a990008387380403321 952 $aP-03a-001$bIst. 3798$fILFGE 952 $aP-03a-002$bIst. 3798$fILFGE 959 $aILFGE 996 $aRoma$9724298 997 $aUNINA LEADER 04605nam 2200613Ia 450 001 9910966008503321 005 20251017110106.0 010 $a0-309-25397-7 010 $a1-283-63629-8 010 $a0-309-25395-0 035 $a(CKB)2670000000241229 035 $a(SSID)ssj0000665824 035 $a(PQKBManifestationID)11378645 035 $a(PQKBTitleCode)TC0000665824 035 $a(PQKBWorkID)10634805 035 $a(PQKB)11281428 035 $a(MiAaPQ)EBC4420874 035 $a(Au-PeEL)EBL4420874 035 $a(CaPaEBR)ebr10594226 035 $a(CaONFJC)MIL394875 035 $a(OCoLC)923289258 035 $a(DNLM)1592184 035 $a(EXLCZ)992670000000241229 100 $a20120705d2012 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aGenome-based diagnostics $eclarifying pathways to clinical use : workshop summary /$fSteve Olson and Adam C. Berger, rapporteurs ; Roundtable on Translating Genomic-Based Research for Health, Board on Health Policy, Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$d2012 215 $axx, 83 p. $cill. (some col.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 08$a0-309-25394-2 320 $aIncludes bibliographical references. 327 $aIntroduction -- Calls for Change -- Test Developers -- Patients -- Payers --Regulation, Reimbursement, and Public Health -- Discussion of Major Proposals -- References -- Appendix A: Workshop Agenda -- Appendix B: Speaker Biographical Sketches -- Appendix C: Statement of Task-- Appendix D: Registered Attendees. 330 $a"The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic interventions, predict risk or onset of disease, or detect residual disease. As research progresses and an increasing number of associations are found, further tests will be developed that can aid in providing personalized treatment options for patients. However, the adoption of genomic diagnostic tests by health care providers has been limited due to a lack of evidence regarding the clinical utility of many tests. Health funders and practitioners lack the data necessary to distinguish which tests can improve practice or the clinical settings in which tests will provide the greatest value. The Roundtable on Translating Genomic-Based Research for Health held a workshop in November 2010 to determine what evidence is needed and how it is viewed by different stakeholders in order to develop genomic diagnostic tests of clinical value. Genome-Based Diagnostics summarizes the presentations and discussions that took place throughout the workshop. Two presentations, in particular, sparked extensive discussion. One presentation proposed that all genomic diagnostic tests be reviewed and approved by the Food and Drug Administration. The other observed that venture capitalists are no longer investing substantially in the development of genomic diagnostic tests because of a lack of clarity surrounding regulatory and reimbursement pathways. Both presentations suggested the need for major changes in the systems used to develop, regulate, and reimburse genomic diagnostic tests. The report also presents the perspectives of different stakeholders in the development of genomic diagnostic tests. Each stakeholder group has a different set of needs and issues of importance, yet commonalities among them are apparent, such as the need to put patients and health outcomes at the center of discussion and action"--Publisher's description. 606 $aHuman chromosome abnormalities$xDiagnosis$zUnited States$vCongresses 606 $aGenetic disorders$xDiagnosis$zUnited States$vCongresses 615 0$aHuman chromosome abnormalities$xDiagnosis 615 0$aGenetic disorders$xDiagnosis 676 $a616/.042 701 $aOlson$b Steve$f1956-$0488724 701 $aBerger$b Adam C$01120088 712 02$aInstitute of Medicine (U.S.).$bRoundtable on Translating Genomic-Based Research for Health. 712 12$aFacilitating Development and Utilization of Genome-Based Diagnostic Technologies: A Workshop$f(2011 :$eWashington, D.C.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910966008503321 996 $aGenome-based diagnostics$94447266 997 $aUNINA