Proprietary and Confidential

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Ryan Phelan CEO Founder October 18, 2006
Proprietary and Confidential
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About DNA Direct
What We Do Medical and pharmaco- genetic testing
and interpretation services firm based in San
Francisco, CA. www.DnaDirect.com www.GenesandDrugs
.com Who We Are CEO Founder, Ryan
Phelan Medical Director, Katherine Rauen, MD
PhD Director of PGx, Huijun Ring, PhD Clinical
Director, Elissa Levin, MS CGC Business
Development, Jason Bobe Our Mission To bring
the power of personalized medicine to patients
reducing health risks, preventing disease, and
better targeting therapies.
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Tamoxifen 2D6 Our Position, Part I
Recommend relabeling tamoxifen with 2D6 evidence
for Post-menopausal women considering tamoxifen
as adjuvant therapy. Our rationale Post-menopau
sal women currently have two treatment
options (1) Sequencing tamoxifen and an AI (2)
AI alone, which is equivalent or better than
treatment option 1. 2D6 testing will Enable
post-menopausal women to make more informed
treatment decisions about tamoxifen Avoid
potentially ineffective therapy and reduce the
risk of breast cancer recurrence The risks
are too great not to recommend 2D6 testing for
post-menopausal women.
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Tamoxifen 2D6 Our Position, Part II
Further Recommendations for 2D6 testing We do
not recommend routine 2D6 testing for pre- and
peri-menopausal women for purposes of clinical
decision-making at this time. Our
rationale Pre- and peri-menopausal women do not
have proven treatment alternatives that are
equivalent to or better than tamoxifen.
Existing alternative therapies include ovary
suppression or removal, and may have significant
long-term adverse consequences, such as
infertility. More definitive evidence is needed
for pre- and peri-menopausal women before 2D6
genotyping should effect clinical
decision-making. Anne-Renee Hartman MD and Paul
Helft MD. The Ethics of CYP2D6 Testing for
Patients on Tamoxifen Journal of Clinical
Oncology, submitted.
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Call for fast-tracking research

• More Research is Needed
• Research on 2D6/tamoxifen needs to be
  fast-tracked
• The livelihoods of thousands of women are at
  stake, tamoxifen may be acting as a placebo for
  5-10 of women currently on the drug (estimated
  500K).
• DNA Directs Efforts to Advance Tamoxifen
  Research
• Greater Baltimore Medical Center
• IRB approved 9/18/06 for retrospective analysis
  of tamoxifen response and 2D6 genotype using
  their breast cancer registry, in process
• Memorial Sloan-Kettering Cancer Center, Mark
  Robson MD
• IRB in development for study evaluating
  tamoxifen/2D6 in pre-menopausal women
• Enable fast-tracking with innovative uses of the
  web to (1) recruit motivated, geographically
  dispersed patients (2) perform aspects of the
  study itself.