1. Jan 2002 EDMA The central role of the Medical Laboratory in a World of Managed Health An EDMA presentation of the benefits of in vitro testing as a basis for better decisions in health care

2. Jan 2002 EDMA In Vitro Testing: Health Information Technology u Medical Laboratory testing is highly automated and provides increasing quantities of valuable data at low cost. u The information about health that this data provides is a basis for better decision-making in health care < by medical professions in management of trauma and disease < by individuals for evaluation and maintenance of their own health < by health economists to assess the value of medical interventions u However, medical professions are often poorly informed about advances in in vitro testing and opportunities to improve health are lost u The public is becoming aware of health care interventions and the value of in vitro testing, via media stories and increasingly via the Internet u This will inevitably lead to changes in the way health care is delivered For better decisions in health care

3. Jan 2002 EDMA Risk by Chance Risk by Choice Genetics, trauma Diet, lifestyle Collective responsibility Individual responsibility Insurable collectively Still insurable collectively Disease Management Health Management “Patients” “People” Medical responsibility Personal responsibility Collective Individual u Choices imply responsibility as well as freedom u Individual choices can greatly increase risk of disease u Better individual choices lead to better health Why do we need health care? Risk and Responsibility for Health Better individual health management now will reduce the need for medical intervention later

4. Jan 2002 EDMA Screening and Prevention u Screening targeted populations for disease risk u Providing information about predisposition to disease / genetic testing u Preventing spread of infection, e.g. via the blood supply u Ensuring continued health and avoiding disease as part of individual responsibility for health In vitro testing : an investment in health care

5. Jan 2002 EDMA Diagnosis, the key to effective treatment u Early and correct diagnosis is the key to effective treatment < Late diagnosis : possibly ineffective treatment of advanced disease < Incorrect diagnosis : incorrect treatment u Family Practitioner is the diagnostic gatekeeper for treatment < not aware of the wide range of very sensitive & specific tests < not able to use the results to full advantage u Patients / public beginning to learn from Internet < Patients are interested in early and correct diagnosis < The “impatient” patient u Normal results eliminate doubt, rule out unnecessary interventions, provide reassurance Early and correct diagnosis ensures that subsequent treatment is appropriate and effective

6. Jan 2002 EDMA u Evaluating patient’s condition during treatment u Reassessment and update of treatment u Monitoring and managing treatment (theranostics), for example < self-testing in diabetes < determining susceptibility to antibiotics < therapeutic drug monitoring in immunosuppression u Objective information for Evidence Based Medicine u Genomic pharmaceuticals (drugs tailored for the individual) u Rehabilitation and wellness testing Therapy & Rehabilitation Laboratory testing provides objective information in evaluating the effects of treatment and a return to health

7. Jan 2002 EDMA In Vitro Testing: An enabling technology u Advanced technologies < antibody-based immunoassays, fluorescent markers < nucleic acid probes, genetics < surface nano-techniques (diagnostic chips) u In vitro testing is an enabling technology < allows self testing and individual responsibility for health < can provide genetic data about disease risk factors < is the basis of genomic drug therapy, pharmaceuticals tailored to the individual and patient selection for drug therapy. < provides objective information for evidence based medicine u Reimbursement systems must become adaptable and flexible to support health management and the adoption of this enabling technology

8. Jan 2002 EDMA In Vitro Testing: Providing evidence for medical interventions u Evidence Based Medicine < Resource allocation in health care increasingly requires evidence of effectiveness / benefit < Increased use of laboratory testing will provide the objective evidence that is needed to assess medical treatments u Evidence based in vitro testing < In vitro test results provide information as a basis for better medical decision making. Most tests provide incremental information in a wide variety of clinical situations: difficult to measure the value of a single test result in a given clinical situation. Section B includes examples of benefits of in vitro testing In vitro testing : for better decisions in health care

9. Jan 2002 EDMA In Vitro Testing: Cost-effective to test more u In vitro tests < 1% of total health care costs < increased testing cannot significantly increase costs of health care < increased testing will allow earlier and more correct treatment, decreasing the costs of health care long term u Personnel costs are the dominant expense in health care < consultation time : expensive for doctor and patient < automated laboratories : cost / test decreased 50 % in 10 years u A possible future for in vitro testing < self ordering of tests - individual awareness < multi-parameter tests done on small sample (diagnostic chip) < results available and commented on by “Internet Consultant” < individual consults with peers and family < first visit to family physician if needed u Reimbursement systems out of phase with possible developments

10. Jan 2002 EDMA In Vitro Testing: Benefits u EDMA approach < Does the treatment or intervention benefit the patient? < Does it have a clinical benefit? < If so, is it affordable and who should pay for it? u To view EDMA’s presentation on the benefits of in vitro testing, including examples click here u In vitro testing provides: < patient benefits < clinical benefits and < economic benefits The basis for better decisions in health care

11. Jan 2002 EDMA Contribution to Individual/Patient satisfaction u Providing information u Enabling self treatment u Preventing infections u Avoiding unnecessary, painful or invasive treatment u Avoiding relapses, delaying complications u Getting better faster u Reducing hospital stay, reducing family disruption Meeting consumer expectations In vitro testing provides objective information when assessing treatment Positive effect of normal results u for individuals - confirming health u for doctors - removing doubts

12. Jan 2002 EDMA Clinical contribution u Valid, quantified information in a simple format u Vital component in evaluation of treatment u Definitive diagnosis / appropriate treatment u Reduction of morbidity u Risk prediction and reduction u Improved compliance u Monitors / quantifies therapy u Scientific basis for therapy and rehabilitation The medical laboratory is an indispensable part of the practice of medicine Objective information As a basis for better decisions

13. Jan 2002 EDMA Economic contribution u Accurate diagnosis u Helps to rule out expensive treatments u Allows procedures and drugs to be targeted u Reduces long term drug treatment u Improves compliance u Reduces costs of treatment of complications u Faster diagnosis u Makes therapy more effective u Containment of disease, lowers risk of infection Avoiding unnecessary treatment Shortening length of hospital stay Investment in in vitro testing provides economic benefits, reducing overall healthcare expenditure

14. Jan 2002 EDMA Establishing the value of laboratory medicine u Medium to long term benefits of laboratory testing < screening to prevent infection and provide information about risk of disease < early & correct diagnosis ensuring subsequent treatment is relevant and cost-effective < monitoring recovery from trauma and effects of treatment, that allow for reassessment and updating of therapy < objective information supporting Evidence Based Medicine < targeting drug treatments according to patient response In vitro testing is the basis for better decisions in health care