About Genomic Health, Inc.

Genomic Health is committed to

prolonging and enhancing
the lives of patients with cancer

• Incorporated August 22, 2000

– Currently 450+ employees
• Located in Redwood City,
California
– All tests ordered by physicians
– 20,000 sq. ft. clinical lab with CLIA
certification and College of American
Pathology (CAP) accreditation
• Recognized Leader in
advancement of Personalized
Medicine
– Member of 21st Century Medicine
Coalition and American Clinical
Laboratory Association

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 The Facts…
U.S. Healthcare Costs Are Soaring

Source: Burrill & Company 2009 Biotech Report

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 "One-Size-Fits-All" Medicine is Not Sustainable,
Does Not Deliver Optimal Results

Source: Burrill & Company 2009 Biotech Report

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 Example of Treatment of a Common Cancer Today

Hormone Receptor Positive, Early Stage Breast Cancer

• Over 400,000 patients worldwide are diagnosed each year
– Most of these patients are offered chemotherapy, knowing that few
benefit
• Only 4 of 100 women with node negative breast cancer benefit
from chemotherapy
• Toxicity is experienced by all
• Direct costs of adding chemotherapy is approximately $31,000 per
patient

Genomic Health provides individualized treatment

planning for patients based on the genomics of their
tumors.
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 Extensive Clinical Validation
More than 4,000 Patients Studied in 13 Trials

Study Type No. Pts Nodal Status

Providence Exploratory 136 Neg

Rush* Exploratory 78 Pos

NSABP B-20 Exploratory 233 Neg

NSABP B-14* Prospective 668 Neg

MD Anderson* Prospective 149 Neg

Kaiser Permanente* Prospective Case-Control 790 Cases/Controls Neg

NSABP B-14 Prospective Placebo vs Tam 645 Neg

Milan* Exploratory 89 Neg/Pos

NSABP B-20* Prospective Tam vs Tam+Chemo 651 Neg

ECOG 2197* Exploratory and Prospective 776 Neg/Pos

SWOG 8814* Prospective Tam vs Tam+Chemo 367 Pos

ATAC* Prospective Tam vs AI 1231 Neg/Pos

Japan BCRG Study* Prospective 280 Neg/Pos

*Published studies

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 Oncotype DX Breast Cancer Test Today

• Oncotype DX Extensively Reviewed

– Oncotype DX Included in Published Breast Cancer Clinical Practice
Guidelines
– American Society of Clinical Oncology (ASCO) Panel (Harris et al, J ClinOncol 2007)
– National Comprehensive Cancer Network (NCCN) (http://www.nccn.org)

– Oncotype positively reviewed by NY’s CLEP and BlueCross/BlueShield’s

Technology Evaluation Center
• Widespread Physician Usage and Adoption
– 150,000+ Oncotype DX breast test results delivered (all performed in
Redwood City, CA)
– >8,000 physicians have ordered the test
– >55 countries using Oncotype DX breast cancer test
• Reimbursement in the U.S. and other countries
– Wide coverage in the U.S.
– Coverage for all Medicare patients ; Coverage >90% of privately insured lives

– Growing coverage in other countries

– Canada, Israel, Greece and Germany

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 Innovation is Dependent Upon Reasonable
and Predictable Regulatory Oversight
• Clear, Predictable, Non Duplicative Oversight
– Recognition of existing CLIA and State oversight of laboratory operations

• Additional Oversight of Tests Already in Use

– Must not result in disruption of current care

• Product Review Standards

– Consistent with evolving standards among experts in the field as
demonstrated by professional guidelines based upon evidence reviews
– Evidence requirements that appropriately lead to cleared intended use
claims that reflect the real use of these tests, for example, as an aid in
treatment selection

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