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Genelex Corporation Release: Coumadin (warfarin) Patients Receive New FDA Information


8/17/2007 11:15:53 AM

SEATTLE, Aug. 17 /PRNewswire/ -- The FDA has announced important changes in the warfarin label, recommending that a lower initial warfarin dose "should be considered for patients with certain genetic variations."

Warfarin (Coumadin) is a commonly prescribed blood thinner with an exceptionally narrow safe-dosage range that varies dramatically from patient to patient.

Historically, determining the correct dose often took multiple clinical visits and blood tests over several weeks or months. Until the correct dosing was established, patients were vulnerable to potentially deadly clotting events such as stroke, and side effects such as hemorrhages, excessive bruising or internal bleeding.

Simple genetics testing done at the beginning of warfarin therapy can help reduce serious adverse reactions to the drug, by quickly determining safe and effective dosing levels based on the patient's unique genetic makeup.

The AEI-Brookings Joint Center estimates that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually, reducing costs by an estimated $1.1 billion annually.

Howard Coleman, Founder and CEO of Seattle's Genelex Corporation, is enthusiastic about the FDA's new labeling. "This is a perfect example of the movement towards personalized medicine, medicine that is prescribed based on the patient's own DNA. The age of trial-and-error prescribing is ending -- as it should".

Coleman continued, "Genetic testing at the initiation of warfarin therapy will save money and lives. Warfarin DNA testing is the most obvious example of how genetic technology can be applied to improve patient care."

Genelex Corporation, one of the country's oldest and most-respected genetic testing laboratories, has offered DNA testing that helps determine warfarin dosage guidelines by genotype for several years.

GENELEX FOUNDER AND CEO HOWARD COLEMAN IS AVAILABLE TO ANSWER REPORTERS' QUESTIONS. INTERESTED REPORTERS MAY PHONE MR. COLEMAN AT (800) 523-3080.

Genelex Corporation, Seattle, Washington is a medically licensed DNA testing laboratory dedicated to bringing the benefits of genetic testing to patients and their physicians. Genelex also provides GeneMedRx, software that helps interpret DNA test results within the framework of an individual's overall medication regimen. For further information about the DNA testing, contact Howard Coleman at Genelex, (800) 523-3080.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Howard Coleman http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=44528 /

Genelex Corporation

CONTACT: Howard Coleman of Genelex Corporation, 1-800-523-3080



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