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Latin American Pharmacogenomic Congress "Delivering the value of personalized medicine to Physicians, Patients and Payors“ David Logan Executive Vice President, Genomic Health, Inc.

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Page 1: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Latin American Pharmacogenomic Congress

"Delivering the value of personalized medicine to Physicians, Patients and Payors“

David Logan

Executive Vice President, Genomic Health, Inc.

Page 2: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

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Safe Harbor Statement

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements related to future periods, can be identified by words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends” and similar expressions, and may include our future plans and prospects and our product pipeline. Forward-looking statements are subject to risks and uncertainties which may cause actual results to differ materially. For a discussion of the factors that may cause our results to differ, please refer to our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX™ and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

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Page 3: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

"Delivering the value of personalized medicine to Physicians, Patients and Payors"

3

• US Road map to providing a more precise tool (Oncotype DX™)

for making critical treatment decisions in early stage breast

cancer…

– Clinical Development and Validation

– Regulatory and Reimbursement Approaches

– Gaining Practice Guideline Recommendations

– Changing Clinical Practice

• International Road Map for Oncotype DX™

– World wide

– Latin America

Page 4: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Genomic Health, Inc

• Genomic Health, a life science company founded August of 2000

• Committed to improving the quality of cancer treatment decisions

• Clinical Reference Lab located in Redwood City, California

• Developed and follow a highly specialized process that (IVD/MIA);

• adheres to CAP (College of American Pathologists) standards

• is regulated by CLIA (Clinical Laboratory Improvement Amendments)

• First Product launched (Oncotype DX™ Breast $3,460) in 2004

• Over 9,000 Physicians have used Oncotype DX

• Over 150,000 patients have been tested to date (50,000 in 2009)

• Orders from over 55 countries

• 5 Product enhancements/new indications in 5 years

• 2009 Revenue $150 Million (Year over Year Growth >40%)

• Second Product (Oncotype DX™ Colon $3,200) in Feb. 2010

4

Page 5: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Drug Development Spending is Significantly Outpacing ResultsThe Facts…U.S. Healthcare Costs Are Soaring"One-Size-Fits-All" Medicine is Not Sustainable, Does Not Deliver Optimal ValueCurrent Allocation of Healthcare Resources is Not Balanced for a Solution

5

Source: Burrill & Company 2009 Biotech Report

In Vitro Diagnostics

Administration

Personnel Cost

Drugs

Procedures

12%

35%18%

35%

Page 6: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

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Personalized Medicine, Center of the Conversation. Products like Oncotype DX have offered a solution

“Oncotype DX is evidence that personalized medicine can help reduce health costs, saving an average of $2,000 per patient in additional costs from chemotherapy

treatment.” – Dr. Francis Collins, Director of the National Institutes of Health

Personalized Medicine

Economy in Crisis

Healthcare Spending

Soaring

Healthcare Reform

TechnologyAccelerating

“We spend far more on treating illnesses that could have been managed for far less.”– President Barack Obama

Page 7: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Oncotype DX™: Unmet Clinical Need for Better Markers

Biopsy

or

Resection

Optimize

chemotherapy

Optimize local

therapy and

hormonal

therapy

Robust

Markers

High risk/Large chemo benefit

Low risk/Little chemo benefit

Page 8: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Our 1st Product was in Breast Cancer in 2004 Why was a personalized approach needed?

8

1 For node-negative breast cancer (Lancet 1996 Apr 20; 347(9008):1066-71)* estimated

• In early stage Breast Cancer, Node (-), Hormone Positive (ER+) patients have ~15% rate of distant recurrence when treated with Hormonal therapy alone

• Chemotherapy benefit is modest in this setting (~4%)1 yet it is recommended for most patients by NCCN guidelines

• We needed an assay to identify a patients risk of distant recurrence AND who benefits from chemotherapy

• One size does not fit all!

Page 9: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

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Candidate Gene SelectionFrom ~30,000 genes

250

cancer-related

candidate genes

*Sources include:

1) Van 't Veer et al, Nature 415:530, 2002

2) Sorlie et al, Proc. Natl. Acad. Sci. 98:10869, 2001

3) Ramaswamy et al, Nature Genetics 33:4, 2003

4) Gruvberger et al, Cancer Res. 61:5979, 2001

Paik et al, SABCS

rtPCR

NSABP B-20

Study,

Pittsburgh, PA

Rush Presbyterian,

Chicago, IL

Providence St.

Josephs Hospital,

Burbank, CA

Page 10: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

The Most Robust (21) Genes were selected to go in Clinical Validation and Confirmation Trials

PROLIFERATION

Ki-67

STK15

Survivin

Cyclin B1

MYBL2

ESTROGEN

ER

PGR

Bcl2

SCUBE2

INVASION

Stromolysin 3

Cathepsin L2

HER2

GRB7

HER2

GSTM1

REFERENCE

Beta-actin

GAPDH

RPLPO

GUS

TFRC

Best RT-PCR performance

and most robust predictors

CD68

BAG1

Paik et al, SABCS

• 13 Key Peer Review

Publications

• Over 4,000 Patients

• Consistent Results

• Oncotype DX

identifies patients

more or less likely to

have a recurrence

AND who will benefit

from chemotherapy

Page 11: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

The Oncotype DX® Recurrence Score is a Continuous Predictor of Recurrence Risk

Dotted lines represent 95% CI

Dis

tan

t R

ecu

rren

ce a

t 10 Y

ears

LOWER RISK HIGHER RISKWhat is the 10-year probability of distant recurrence

for a patient with a Recurrence Score of 30?

Recurrence Score

RS 30 = 20% risk of

distant recurrence at

10 years

Page 12: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Multiple Independent Studies Confirm -Decision Impact Supports Clinical Utility

Treatment Received by Recurrence Score1

1 Liang, SABCS 2007, Abstract #2061

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Page 13: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

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Building the Breast Cancer Franchise

Investment in Clinical Studies Expands Value to Patients

2008

Quantitative Single Gene

2007

Node Positive Recurrence,

Chemotherapy Benefit

2005

Node Negative Chemotherapy

Benefit2004

Node Negative Recurrence

Page 14: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Publications

• California Technology Assessment Foundation

• Agency for Healthcare Research and Quality

• Blue Cross Blue Shield Technology Evaluation Center• Approval of Appropriate Governmental Regulatory Bodies

• Analytic and Clinical Validity

• Clinical Utility must Improve Net Health Outcomes

• Benefit Beyond Established Measures

• Benefit Outside of Investigational Setting

• ASCO Guidelines

• NCCN Guidelines

• US Private Payor Coverage = 98%

• Medicare Coverage = 100%

Page 15: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

92%8%

Low Risk

High Risk

NCCN Classification

49%

29%

22%

Low Risk

Intermediate Risk

High Risk

RT-PCR Assay

Reclassification

72%

6%

22%

Low Risk

Intermediate Risk

High Risk

RT-PCR Assay

Reclassification

Comparative Effectiveness: Relationship of NCCN vs. RS Directed Classification

Page 16: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Source: US adjuvant chemo usage data for early stage N- patients from OncoReport ICI; Oncotype DX data from

Genomic Heath

The Treatment Paradigm Has Changed

Page 17: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Key Milestones

• NSABP B14 Publica-tion

• NSABP B20 Presenta-tion

• Kaiser Presenta-tion

• Medicare Coverage

• NSABP B20, Kaiser Publicat-ions

• Aetna, United, Cigna Coverage

• ASCO and NCCN Guidelines

• SWOG 8814 Presenta-tion

• HER2, ER and PR Scores

• Node + Report

• Aromatase Inhibitors

• 90% U.S. Coverage

Consistent Adoption of our Product line.> 150,000 Patients benefited from Oncotype DX

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• Inter-national expansion

• Japanese Clinical Results

• Node + Medicare Coverage

• Latin Am. Expansion

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

2004 2005 2006 2007 2008 2009 2010

500

7,000

15,000

25,500

40,000

52,000

60-65K Est.

Page 18: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Our Integrated Service Model

Physicians

PatientsPayors

Direct-to-Oncology Sales

Reproducible Standardization

Publications – Evidence Driven

Guidelines – Evidence Supported

CME/Medical Staff

Outstanding Lab and Path Support

World Class Customer Service

Reimbursement Support

Patient Education Programs

Patient Advocacy

Patient Support - GAP

Managed Care

Evidence-Based Appeals

Effective Utilization Outcomes

Clinical Pathways

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Page 19: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Redwood City Clinical Reference Lab

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SARPCRM

SARPCRM

GEMTools (LIMS)

Material Manager

Data Services

OnBase EDI Services

Online Portal

EDI Services

Online Portal

Material Manager

HARP

PAS

Result Generation

Service

Report Delivery

Electronic Claim

ORDER ENTRY INTAKE PATHOLOGY ANALYTICAL

LABORATORYREPORT

FULFILLMENTMATERIAL RETURN

Insurance Provider

Order Entry

Benefits Investigation

Patient Information

Retrieval

SpecimenRetrieval

SpecimenAccessioning

Pathology Review

HistopathologyDissection

Extraction

Quantitation

gDNA Detection

Reverse Transcription

Results Generation

Billing

Report Delivery

MaterialsReturn

Reimbursement

Online, Fax FedEx

QPCR

Online Fax

Phone

Fax Request

FedEx FedEx

Our U.S. lab has processed tests from more than 55 countries to date.

Page 20: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

A Personalized Medicine Approach Driving a New Standard of Care

•In Summary……

Page 21: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Product Pipeline - Positioned for Growth

Colon

Prostate

Breast

Renal

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Puerto Rico

• We placed a Representative in Puerto Rico 2009• > 60 MD’s have placed order• > 400 Patients have utilized Oncotype DX• Medicare patients and 100% Coverage• Triple S - Has a policy, working on a contract• Humana - Discussion ongoing (US Policy/Contract)• MSC – Has policy, working on contract

Page 22: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

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International Expansion (2nd Year)

Countries that have submitted samples

Distribution partners

Sales/Consultants

Geneva Switzerland EU Office

1 Globocan 2002/ACS Cancer Facts & Figures 2007

Global incidence of breast cancer ~ 1.3 million patients1

Geneva Switzerland Office

Building the infrastructure. Establishing clinical experience and usage while advancing reimbursement submissions in targeted countries

Highlights:

• 56 Countries have ordered at least 1 assay• >8,200 Assays Launch to date• >1,100 Physicians • >50% YOY grow• 8 Ongoing studies (Utilization, Patient Selection)• Public and/or Private Coverage

• Germany (Public)• UK (Private)• Greece (Public)• Canada (Public, Province of Ontario)• Israel: (Public/Private)

• Patient (Cash) or Hospital payment is still the primary reimbursement

Page 23: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Latin American Presence & Progress: 2 Years of Effort – General Comments

• Awareness of Personalized Medicine: Hot Topic – The Promise of the future!

• Awareness of Oncotype DX: Growing with ~800 assays requested and by over >160 physicians and >50% YOY

• Treatment patterns and therapeutic options

– Less Early Stage patient presentation

– Adjuvant Treatment less aggressive (availability)

• Pathways to regulatory approval for IVD/MIA type products not always clear (FDA vs. CLIA)

• Public Reimbursement (~90%)- No Coverage to Date: Reason: Priorities, Access to Care, Pharmacoeconomics differ, Incentives favor treatment, patients pathway to coverage is difficult (legal petition)

• Private Coverage (10%) – encouraging: Private Insurers, Key Hospital and patient pay represent the early supporters of Oncotype DX

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Page 24: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Latin America Progress

Mexico

Seeking Partner /Study

Private Coverage: Hospital

Public Coverage: Pending

Promising: Mexican Social

Security Institute (IMSS) are

evaluating and Draft guidance

and Consenso Mexicano

(Secretaria de Salud) plan to

include Oncotype DX

Venezuela

Distributor: Fundacion BADAN

Private Coverage: Seguros

Caracas, Seguros Mercantil,

Sanitas de Venezuela,

Multinacional de Seguros

Public - IVSS (Social

Security) has paid first claim

Brazil / Study

Distributor: Diagnostika

Private market is

currently only viable

option for market entry.

Public: Not a current

option

Peru / Study

TAILORx study at the Instituto

Nacional de Enfermedades

Neoplasicas – Hospital Coverage

Colombia (+ Costa Rica and

Panama)

Distributor: Amarey Nova

Private Coverage: MCO’s -

Colsanitas and Saludcoop Argentina

Seeking Partner:

Will target Obras

Sociales (Unions) and

PAMI (Argentina

Medicare)

Page 25: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

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Personalized Medicine is at the Center of the Conversation… Products like Oncotype DX offer a solution

“Oncotype DX is evidence that personalized medicine can help reduce health costs, saving an average of $2,000 per patient in additional costs from chemotherapy

treatment.” – Dr. Francis Collins, Director of the National Institutes of Health

Personalized Medicine

Economy in Crisis

Healthcare Spending

Soaring

Healthcare Reform

TechnologyAccelerating

“We spend far more on treating illnesses that could have been managed for far less.”– President Barack Obama

As the IVD/MIA Space Moves Foreward

• Regulatory Pathway• Standards in Tec Assessment – Levels of Evidence• Value Proposition and Pricing (CPT System)• Alignment of Incentives• Education• Access

Page 26: to Physicians, Patients and Payors“ · "Delivering the value of personalized medicine to Physicians, Patients and Payors" 3 •US Road map to providing a more precise tool (Oncotype

Latin American Pharmacogenomic Congress

Thank You!