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

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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