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Diagnostic Insights

Diagnostic Insights. Excerpts from White Paper. 2012. Mission Statement. DxInsights ’ mission is to educate healthcare industry executives, policymakers, payers and healthcare advocates on the power and value of diagnostics and their impact on improving patient outcomes and reducing costs.

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Diagnostic Insights

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  1. Diagnostic Insights Excerpts from White Paper 2012

  2. Mission Statement DxInsights’ mission is to educate healthcare industry executives, policymakers, payers and healthcare advocates on the power and value of diagnostics and their impact on improving patient outcomes and reducing costs

  3. Business Summary • DxInsights is a non-profit educational organization devoted to the education of healthcare industry executives, policymakers, payers and advocates on the power and value of diagnostics and their impact on improving patient outcomes and reducing costs today, and the promise of an even betterfuture. • DxInsights provides education through multiple outlets, including a comprehensive on-line resource center, original research, educational events, and additional events. • DxInsights was founded by and is led by seasoned healthcare industry executives with a focus and expertise on diagnostics and the desire to come together as a community to meet this unmet need. The organization is incorporated as a 501c3 non-profit organization. • DxInsights encourages any and all members of the healthcare community to join DxInsights at no charge. Funding is through educational grants and sponsorships.

  4. Educational Resource Center Model Web-based Resource Center Educational Events DxInsights www.dxinsights.net Online Community Original Research • DxInsights is a first-in-class industry wide educational organization devoted entirely to diagnostics. Excerpts from our inaugural white paper are enclosed in the attached slides.

  5. Background • Diagnostic tests inform 60% of clinical decision-making, but make up less than 2% of the healthcare spend. Source: DxInsights White Paper January 2012

  6. Diagnostics Categorization • Diagnostics can be categorized into in vitro diagnostics (IVD) and in vivo diagnostics. Diagnostics In Vitro Diagnostic Tests In Vivo Diagnostic Tests • Tests that assess health status inside of the body or • measure body functions by testing samples taken from inside the body • Examples: • Pregnancy test • Blood chemistry • Cholesterol test • Glucose monitoring • PSA test • Pap smear • Tests that assess health status inside of the body or • measure body functions by testing outside of the body • Examples: • X-ray • Temperature • Blood pressure screening • Ultrasound • MRI • Heart rate monitor Source: DxInsights White Paper January 2012

  7. Comprehensive Role of Diagnostics • Diagnostics can help clinicians optimally manage patients through the continuum of care. Risk Assessment Screening Diagnosis Staging and Prognosis Therapy Selection Monitoring Source: DxInsights White Paper January 2012

  8. HIV: A Progression in Diagnosis and Treatment • The evolution of diagnostics for HIV identification and subsequent care is a good example of the diagnostic industry progress over time. 2011 The first over the counter (OTC) HIV test being reviewed by the FDA 1981 Official beginning of the HIV/AIDS epidemic with the MMWR report of 5 cases of PCP 1994 FDA approves first oral test for diagnosis of HIV 2007 Trofile launched, a companion diagnostic to the drug Selzentry , indicated for patients infected with CCR5-tropic HIV 1985 First HIV antibody test licensed by FDA detects antibodies to HIV and aids in diagnosis 2000 1990 2010 1980 1983-84 Isolation of virus 1992 FDA licenses first rapid HIV test for diagnosis of HIV AMA recommends resistance testing to help determine a patient's initial antiretroviral regimen only if there are factors that indicate an increased risk for resistance HIV diagnostics now span entire spectrum of disease management, from screening to diagnosis to treatment selection to monitoring 1996 FDA approves first viral load testing that measures HIV in the blood, specifically the number of copies of viral RNA per one mL of blood Source: DxInsights White Paper January 2012

  9. AlloMap Economic Argument • Today, many innovative diagnostics are backed by clinical and economic data supporting their use. AlloMap System Economics Study Five Year Monitoring Costs per Patient $6,511 Cost Savings Per Patient in monitoring costs alone, in addition to avoiding repetitive, invasive heart biopsies * AlloMapis projected to have a 20% follow-up biopsy rate which was included in the analysis. Source: Evans et al. American Journal of Transplantation 2005; 5: 1553-1558. Health Advances analysis. Source: DxInsights White Paper January 2012

  10. US Employment in the Diagnostics Industry Source: DxInsights White Paper January 2012 Diagnostic innovation creates companies and jobs.

  11. Proof Positive: The Human Genome Project 1988-2010 2010 The economic and functional impact generated by the Human Genome Project alone is enormously significant.

  12. Summary and Additional Information • Diagnostics represent the foundation of a successful healthcare system.A new approach to education on diagnostics is needed and a new organization should drive the initiative. • DxInsights is an integrated resource center devoted to education on diagnostics aimed at industry executives, policymakers, payers, industry funders and healthcare advocates. • With your support through membership and sponsorship, DxInsights will provide a world-class resource center for unbiased information on the diagnostics industry across all technologies and a much needed centralized community for all diagnostic stakeholders. • For more information, please visit our website at www.dxinsights.net. • Thank you!

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