1 / 5

Proprietary and Confidential

Ryan Phelan CEO & Founder October 18, 2006. Proprietary and Confidential. 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

penha
Download Presentation

Proprietary and Confidential

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Ryan Phelan CEO & Founder October 18, 2006 Proprietary and Confidential

  2. 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.

  3. Tamoxifen & 2D6: Our Position, Part I • Recommend relabeling tamoxifen with 2D6 evidence for: • Post-menopausal women considering tamoxifen as adjuvant therapy. • Our rationale: • Post-menopausal 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.

  4. 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.

  5. 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 Direct’s 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.

More Related