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Kenneth Sisco, MD, PhD, FCAP Medical Director Quest Diagnostics February 11, 2013

c linical l aboratory t esting : providing c ritical e vidence for diagnosis and treatment. Kenneth Sisco, MD, PhD, FCAP Medical Director Quest Diagnostics February 11, 2013. what are clinical laboratory tests?. Types of Tests Cholesterol Pap Complete blood c ount

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Kenneth Sisco, MD, PhD, FCAP Medical Director Quest Diagnostics February 11, 2013

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  1. clinical laboratory testing: providing critical evidence for diagnosis and treatment Kenneth Sisco, MD, PhD, FCAP Medical Director Quest Diagnostics February 11, 2013

  2. what are clinical laboratory tests? • Types of Tests • Cholesterol • Pap • Complete blood count • Serum albumin • HIV • Leukemia • Clinical Role • Detect • Diagnose • Prevent • Monitor progress • Determine treatment • Inform physicians in medical decisions Clinical lab tests guide health care decisions

  3. a critical distinction Medical imaging tests Clinical lab tests

  4. clinical laboratory profile • 7 billion tests • 5,346 labs • In all 50 states Clinical lab tests constitute only 1.6% ($8.9B) of total Medicare spending

  5. how lab testing works

  6. How labs are regulated Laboratory Personnel Know-How Laboratory Reagents, Equipment Laboratory-DevelopedTest CLIA regulations State regulations CAP accreditation Lab personnel pass CAP proficiency tests FDA regulates individual components

  7. what are the results of lab testing?

  8. rising health costs in the u.s… Chronic Disease = 75% Health Costs Source: CMS, CDC

  9. so what do we do about it? “Although chronic diseases are among the most common and costly health problems, they are also among the most preventable.” Centers for Disease Control and Prevention

  10. Lab tests help Stop diabetes • Diabetes is a killer • Blindness, kidney failure, heart disease • With lab tests, diabetes can be… • Controlled, managed, prevented • Controlling blood sugar levels through lab tests… • 5 more years of life • 8 more years of eyesight • 6 more years without kidney disease Diabetes control vs Diabetes complications Source: Diabetes Care, 1998, 2003; Journal of Managed Care Pharmacy, 2005; Journal of American Med Assn, 1998

  11. why hba1c test is important in diabetes • A simple blood test • Measures blood sugar over 6-12 weeks • Shows how well diabetes is being managed over time • Now also recommended by ADA as effective diagnostic tool • Advantages: • Consumer friendly: no fasting • Accurately reflects blood sugar levels • Less affected by factors as stress or illness • Why important? • Enables proper management • Key to preventing onset of serious complications • Including eye, heart and kidney disease; nerve damage; stroke

  12. lab tests help prevent cervical cancer • Pap tests detect pre-cancerous cells • Early detection, prevention, treatment mean: • Lives saved • Money saved • Costs • Test = $31 • Surgery = $37,000 Source: National Cancer Institute Source: National Business Group on Health

  13. lab tests have transformed hiv • HIV test + HIV drugs = “one-two” punch… • Dramatic decline in deaths • Patients live normal lives • Lab tests tell docs which drug combo will work best • Tests let docs adjust drugs to combat fast-morphing virus • HIV lab tests cost-effective HIV Death Rates, 1987 - 2003 Source: Journal of American Medical Association, 2006; New England Journal of Medicine, 1998; Centers for Disease Control and Prevention

  14. lab tests enable better utilization • KRAS gene mutation • 40% of metastatic colon cancer patients do NOT benefit from drug • Genetic test • Avoid ineffective treatment • Reduce adverse events • $ Savings • One estimate: $100 million • Savings annually if test is done before prescribing Cost of drug per patient: $62,000 Cost of test per patient: $452 Source: Shankaran, V, et al, ”Economic Implications of KRAS testing in metastatic colorectal cancer,” Paper presentation, ASCO, 2009; Manci, Am J Health-Syst Pharm., 2009

  15. genetic test tailors breast cancer care • Analyzes patient’s tumor at molecular level • Estimates likelihood of recurrence within 10 years • Predicts likelihood of chemo benefit • Gives critical info to decide chemo vs no chemo • Average chemo efficacy = 25% • Each year, 60,000 tests… • 30% changed treatment decision • 25% avoided toxicity of unneeded chemo • 5% will add chemo

  16. how much does this matter? 1.6% of Medicare Health care decisions

  17. Resources • American Clinical Laboratory Association • Alan Mertz, President • Francesca Fierro O’Reilly, Legislative Affairs • 202-637-9466 • acla.com • Results for Life • labresultsforlife.org

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