Kenneth Sisco, MD, PhD, FCAPMedical Director
Quest Diagnostics February 11, 2013
CLINICAL LABORATORY TESTING: PROVIDING
CRITICAL EVIDENCE FOR DIAGNOSIS AND
TREATMENT
2
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
WHAT ARE CLINICAL LABORATORY TESTS?
Clinical lab tests guide health care decisions
3
Clinical lab tests
Medical imaging tests
A CRITICAL DISTINCTION
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7 billion tests5,346 labsIn all 50 states
CLINICAL LABORATORY PROFILE
Clinical lab tests constitute only 1.6% ($8.9B) of total Medicare spending
Other Labs4%
IndependLabs33% Hospital
Labs54%
Physician Office Labs9%
Annual Test Volume, 2010
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HOW LAB TESTING WORKS
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HOW LABS ARE REGULATED
CLIA regulationsState regulations
CAP accreditation
Lab personnel pass CAP
proficiency tests
FDA regulates individual
components
Laboratory Reagents,
Equipment
Laboratory Personnel Know-How
Laboratory-Developed
Test
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WHAT ARE THE RESULTS OF LAB TESTING?
Disease Lab Test ResultsCervical cancer Pap Test 75% drop in cervical cancer
mortalityKidney Disease eGFR Early detection helps prevent
kidney failureDiabetes Glucose, HbA1c Appropriate glucose level…
• Lowers eye disease risk 78%• Lowers nerve disease risk 60%• Adds 5 more years of life
Heart Disease Cholesterol, lipids Guide doctors in prescribing drugs that cut heart attacks and strokes
Leukemia Genetic Test Cure rate in childhood leukemia exceeds 80% vs 4% in ‘60s
Colon Cancer Fecal Occult Blood Test
Reduces death rates
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RISING HEALTH COSTS IN THE U.S…
Source: CMS, CDC
1970 1980 1990 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 20110
500
1000
1500
2000
2500
3000
Total Health Expenditures, 1970 - 2011
$ Bi
llion
s
Chronic Disease = 75% Health Costs
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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
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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
Manag
e Diab
etes
Perip
hera
l arte
ry d
iseas
eAm
putat
ion
Hear
t atta
ck
Dialy
sis
$1,852
$5,955
$26,894 $27,630
$53,659
Diabetes control vs
Diabetes complications
Source: Diabetes Care, 1998, 2003; Journal of Managed Care Pharmacy, 2005; Journal of
American Med Assn, 1998
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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
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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
69 71 73 75 77 79 81 83 85 87 89 91 93 95 97 99 '01 '030123456789
Cervical Cancer Mortality Rate, 1969-2004
Dea
ths
per 1
00,0
00 P
op.
Pap Test $31
Treatment for abnormal findings $1,281
Treatment for early stage cervical cancer
$20,255
Treatment for late-stage cervical cancer
$36,912
Source: National Business Group on Health
Source: National Cancer Institute
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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
1987
1989
1991
1993
1995
1997
1999
2001
0
2
4
6
8
10
12
14
16
18
Dea
ths
per
100,
000
HIV Death Rates, 1987 - 2003
Source: Journal of American Medical Association, 2006; New England Journal of Medicine, 1998; Centers for Disease Control
and Prevention
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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
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
LAB TESTS ENABLE BETTER UTILIZATION
Cost of test per patient: $452
Cost of drug per patient: $62,000
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GENETIC TEST TAILORS BREAST CANCER CARE
Analyzes patient’s tumor at molecular level Estimates likelihood of
recurrence within 10 years Predicts likelihood of chemo
benefitGives 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
Cost of Test Savings from less chemo
$238.5M
$372M
Cost, Savings from Testing 60K Patients, $Millions
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HOW MUCH DOES THIS MATTER?
1.6% of Medicare
Health care decisions
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American Clinical Laboratory Association Alan Mertz, President Francesca Fierro O’Reilly, Legislative Affairs 202-637-9466 acla.com
Results for Life labresultsforlife.org
RESOURCES