DENVER, June 5 /PRNewswire/ -- Today marks the launch of Kimball Genetics' innovative pharmacogenetic test for warfarin therapy, the Warfarin DoseAdvise(TM) Genetic Test. The test detects specific variations in the CYP2C9 and VKORC1 genes, the presence of which result in lower dose requirements for warfarin. Kimball Genetics' one-day turnaround time enables clinicians to incorporate Warfarin DoseAdvise(TM) genotype information smoothly into their patient care. Other special features Kimball Genetics provides with this test are detailed reports with interpretation and recommendations as well as genetic counseling for patients and clinicians. In addition, the test can be performed on buccal cells (cheek cells) as a convenient alternative to blood. Accuracy of the test is ~99.9% for either sample type.
"We are excited to be offering the Warfarin DoseAdvise(TM) Genetic Test because of its potential to be of major clinical benefit to so many patients," says Dr. Annette K. Taylor, President and CEO of Kimball Genetics. She points out, "The test identifies patients who are at increased risk for over-anticoagulation, and with our one-day turnaround time we will be able to offer clinicians the answers they need for quickly optimizing dose prior to and during warfarin initiation." Use of genotype information from the test will shorten the time to achieve therapeutic dosing, reduce the number of dose adjustments, and improve the percent of time the patient is in the target therapeutic range.
Pharmacogenetics-based warfarin therapy is an exciting development in medicine being actively adopted into clinical practice. It provides a safer and more streamlined approach to treatment with this drug than has previously been available. The Food and Drug Administration (FDA) is currently involved in rewriting the medical product label for warfarin to advocate genetic testing of patients being initiated on warfarin therapy and to recommend use of lower doses in patients with genetic variants in CYP2C9 and/or VKORC1.
Clinicians can use genotype information from the Warfarin DoseAdvise(TM) Genetic Test in combination with clinical information about their patients to predict the therapeutic dose. An interactive website, at http://www.WarfarinDosing.org, has been developed by Brian F. Gage, MD, MSc, and colleagues at Washington University Medical Center, St. Louis, MO, and is ideal for this purpose. This easy-to-use, practical tool for pharmacogenetics-based warfarin therapy employs several dosing algorithms based on multivariate regression analysis and not only accurately predicts therapeutic dose at the outset of therapy, but allows for refinement of dose using the patient's INR (International Normalized Ratio) value on the third or fourth day of therapy. Based on data from a cohort of orthopedic surgery patients, the clinical and genetic factors in this mathematical model account for 79% of the variability in warfarin dose. In contrast, standard approaches to warfarin therapy use clinical factors that account for just 20% of the variability in warfarin dose.
Warfarin, prescribed to over 2 million patients in the U.S. annually, is the most frequently used oral anticoagulant for the treatment and prevention of thromboembolism. Though very effective, warfarin is difficult to manage because of its narrow therapeutic index and very wide inter-individual variability in response and therapeutic dose. The rate of adverse events, particularly bleeding, is high. On average, patients are above therapeutic range 30% of the time during the first month of therapy, which is the time when bleeding risk is highest. Variants in the CYP2C9 gene cause patients to metabolize and clear warfarin slowly, and the common variant in the VKORC1 gene increases sensitivity to warfarin by reducing availability of vitamin K in the form required for production of vitamin K-dependent clotting factors. The effect of the variants in each case is a decrease in warfarin dose requirement. Numerous studies have confirmed correlations of each genotype with therapeutic dose.
Kimball Genetics is committed to the advancement of pharmacogenetic testing in mainstream medicine and will be expanding their program in this area. "This is the beginning of a new era of personalized medicine which allows for individual customization of drug therapy," remarks Dr. Taylor. The company is a member of the Personalized Medicine Coalition, a non-profit group of academic and industrial organizations, patient groups, and healthcare providers dedicated to increasing awareness and adoption of personalized medicine.
About Kimball Genetics, Inc.
Founded in 1994 by Annette K. Taylor, M.S., Ph.D., Kimball Genetics is a national DNA diagnostic laboratory located in Denver, CO, specializing in testing for common genetic disorders that are preventable or can be treated. Known for its unparalleled turnaround time and distinctive focus on genetic counseling and education, the company's major areas of testing in addition to their new program in pharmacogenetics currently include inherited hypercoagulability, celiac disease, hemochromatosis, cystic fibrosis, and fragile X syndrome.
Kimball Genetics, Inc.