title: The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report.
abstract: BACKGROUND
  In vitro diagnostic (IVD) investigations are indispensable for routine patient management. Appropriate testing allows early-stage interventions, reducing late-stage healthcare expenditure (HCE).
  
  
  OBJECTIVE
  To investigate HCE on IVDs in two developed markets and to assess the perceived value of IVDs on clinical decision-making. Physician-perceived HCE on IVD was evaluated, as well as desired features of new diagnostic markers.
  
  
  METHODS
  Past and current HCE on IVD was calculated for the US and Germany. A total of 79 US/German oncologists and cardiologists were interviewed to assess the number of cases where: physicians ask for IVDs; IVDs are used for initial diagnosis, treatment monitoring, or post-treatment; and decision-making is based on an IVD test result. A sample of 201 US and German oncologists and cardiologists was questioned regarding the proportion of HCE they believed to be attributable to IVD testing. After disclosing the actual IVD HCE, the physician's perception of the appropriateness of the amount was captured. Finally, the association between physician-rated impact of IVD on decision-making and perceived contribution of IVD expenditure on overall HCE was assessed.
  
  
  RESULTS
  IVD costs account for 2.3% and 1.4% of total HCE in the US and Germany. Most physicians (81%) believed that the actual HCE on IVDs was >5%; 19% rated the spending correctly (0-4%, p<0.001). When informed of the actual amount, 64% of physicians rated this as appropriate (p<0.0001); 66% of decision-making was based on IVD. Significantly, more physicians asked for either additional clinical or combined clinical/health economic data than for the product (test/platform) alone (p<0.0001).
  
  
  CONCLUSIONS
  Our results indicate a poor awareness of actual HCE on IVD, but a high attributable value of diagnostic procedures for patient management. New markers should deliver actionable and medically relevant information, to guide decision-making and foster improved patient outcomes.
authors.affiliation: Roche Diagnostics, Sequencing Unit, Pleasanton, CA, 94588, United States of America.
authors.forename: Ulrich-Peter
authors.initials: UP
authors.lastname: Rohr
authors.affiliation: Institute of Surgical Pathology, University Hospital Zurich, 8091, Zurich, Switzerland.
authors.forename: Carmen
authors.initials: C
authors.lastname: Binder
authors.affiliation: Kantonsspital Baselland, 4410, Liestal, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Dieterle
authors.affiliation: European Organisation for Research and Treatment of Cancer, 1200, Brussels, Belgium.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giusti
authors.affiliation: Divisional Medical and Scientific Affairs, F. Hoffmann-La Roche Ltd, 4070, Basel, Switzerland.
authors.forename: Carlo Guiseppe Mario
authors.initials: CG
authors.lastname: Messina
authors.affiliation: Faculty of Economic and Management Sciences, University of Pretoria, 0060, Pretoria, South Africa.
authors.forename: Eduard
authors.initials: E
authors.lastname: Toerien
authors.affiliation: Institute of Surgical Pathology, University Hospital Zurich, 8091, Zurich, Switzerland.
authors.forename: Holger
authors.initials: H
authors.lastname: Moch
authors.affiliation: Divisional Medical and Scientific Affairs, F. Hoffmann-La Roche Ltd, 4070, Basel, Switzerland.|Institute of Anatomy II, University Hospital Jena, Friedrich Schiller University, 07740, Jena, Germany.
authors.forename: Hans Hendrik
authors.initials: HH
authors.lastname: Schäfer
mesh_terms: D000465:Algorithms; D002309:Cardiology / Q000191:economics; D003362:Cost-Benefit Analysis; D003625:Data Collection; D020000:Decision Support Systems, Clinical; D003955:Diagnostic Tests, Routine / Q000191:economics / Q000706:statistics & numerical data*; D005858:Germany; D017048:Health Care Costs; D006801:Humans; D008495:Medical Oncology / Q000191:economics; D010818:Practice Patterns, Physicians'; D011795:Surveys and Questionnaires; D014481:United States