SAN FRANCISCO and SEATTLE, July 10 /PRNewswire/ -- DNA Direct, Inc. and Iverson Genetic Diagnostics, Inc. today announced that the companies will collaborate to offer personalized reports for individuals receiving Iverson's molecular-based assay for testing sensitivity to warfarin, a commonly used anticoagulant. DNA Direct will provide a customized, web-enabled tool for Iverson customers, allowing physicians who work with Iverson to offer their patients a personalized report that explains their test results in a patient-friendly, interactive format.
"By offering these personalized reports to physicians, we hope to maximize the quality of care for patients, enhance communication between patients and providers, and create a strong framework for patient education," said Dean Sproles, CEO of Iverson Genetics. "Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug reactions. We feel that DNA Direct's physician resource will enhance our customer's experience and help us to advance this important type of testing into standard patient care."
Over two million patients are prescribed warfarin in the United States each year, one third of whom metabolize it differently than expected and experience a higher risk of bleeding.(1) Approximately 85,000 serious bleeding events and 17,000 strokes each year could be prevented by formally integrating genetic testing into warfarin treatment, potentially saving up to $1.1 billion annually.(2)
"We believe DNA Direct's clinical resources and genetic expertise will provide additional value to both physicians and patients through this web-based solution," said Ryan Phelan, founder and CEO of DNA Direct. "This collaboration will enable Iverson to offer a time-saving solution for physicians that also harnesses the Web's potential for enhancing patient care and maximizes the value of this diagnostic."
The web-enabled reports will be personalized to the patient's actual test results, explaining the implications for both general drug response and warfarin dosing. The reports will also explain how genes affect drug response, what factors impact warfarin dosing and what next steps may be most appropriate. Patients will be able to download a copy of their lab report, as well as a clinical summary letter to be shared with their physicians. Patients may return to their report at a later date to determine how metabolism status may impact drug response for certain additional medications.
In August 2007, the U.S. Food and Drug Administration (FDA) updated labeling on warfarin, the oral anticoagulant most frequently used to control and prevent thromboembolic disorders, indicating that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug(1). FDA black box warnings flag physicians that patients over 65 years of age carry a higher risk for bleeding and require special vigilance. This information, combined with several clinical studies, has encouraged physicians to recommend genetic testing to better support determining a patient's optimal dose. Too high of a dose contributes to life-threatening bleeding, and too low a dose places the patient at risk of life-threatening blood clots.
About Iverson Genetic Diagnostics, Inc.
Iverson Genetic Diagnostics is a privately held company headquartered at Institute for Systems Biology. Iverson provides genetic testing services nationwide with service representatives calling on physicians and clinics in Washington, Oregon, Texas, Idaho, Montana and Alaska. With a CLIA laboratory and MTS (Medical Testing Site) certification for high complexity molecular genetic testing, Iverson has the capacity for processing 17,500 tests per month. Additional information about Iverson Genetic Diagnostics, Inc. is available at http://www.iversongenetics.com or call toll free (877) 894-4841.
About DNA Direct
DNA Direct is a San Francisco-based, privately held company that provides convenient, clinically valid personal genetic information and testing services to customers, and provides genetic expertise to providers and labs. DNA Direct creates customized, Web-enabled solutions to integrate the value of genetic information into healthcare decisions by filling the gap in genetic expertise and providing a cost-effective way to deliver genetic testing and services. For more information, visit http://www.dnadirect.com.
(1) U.S. Food and Drug Administration. FDA Approves Updated Warfarin (Coumadin) Prescribing Information; New genetic information may help providers improve initial dosing estimates of the anticoagulant for individual patients. (Press Release). August 17, 2007. Available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html
(2) American Enterprise Institute-Brookings Joint Center for Regulatory Studies. Health Care Savings from Personalizing Medicine Using Genetic Testing: The Case of Warfarin. November 2006. Available at: http://aei-brookings.org/admin/authorpdfs/redirect- safely.php?fname=../pdffiles/WP06-23_topost.pdf
CONTACT: Katie Compa, +1-415-946-1078, firstname.lastname@example.org, for DNA
Direct, Inc. and Iverson Genetic Diagnostics, Inc.; or Adam Ward of DNA
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Web site: http://www.dnadirect.com/