Kimball Genetics, Inc. Launches the Warfarin DoseAdvise(TM) Genetic Test, Ideally Suited for Clinicians to Improve Warfarin Therapy

Jun 05, 2007, 01:00 ET from Kimball Genetics, Inc.

    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, 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.

SOURCE Kimball Genetics, Inc.