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Biomarker Development CV
Transgenomic, Inc. has developed industry leading know-how and experience in translating the science relating to genetic marker discovery to valuable applications in the clinical setting. The division is accustomed to discovering and in-licensing proprietary markers including but not limited to those in CNS, cardiovascular, and oncology. Once the genetic marker is known, and clinical utility is evident, Transgenomic, Inc. has the experience to validate and commercialize genetic tests based on these markers. The genetic markers that are developed and included in Transgenomic, Inc.’s test catalog are chosen for commercialization based Transgenomic, Inc.’s assessment of their economic and clinical value to the key consumers of these tests (including patients, providers, payors). In addition, we work directly with those developing therapeutics to identify genetic markers, incorporate the markers into their commercialization plan, and Transgenomic, Inc. is positioned to commercialize the resultant genetic tests for our clients as well in the same manner we commercialize our own genetic tests. Transgenomic, Inc. is committed to funding its in licensing, development and commercialization of these genetic tests but will continue to work with others to accelerate discovery and development where a strategic fit exists.
Why Cardiovascular
From the often asymptomatic diseases of hypertension and hypercholesterolemia to the crushing chest pain of acute cardiac syndromes and the devastation of sudden cardiac death, our understanding of the genetic contribution to cardiovascular disease is increasingly important in determining the best therapeutic options. Family history has long been acknowledged to be a risk factor but now the genetic biomarkers that underlie the familial contribution are being elucidated. Equally important is the role genetics plays in treatment response. Current treatment or management options may have insufficient efficacy (for example, continued anginal pain on maximal medical therapy or post-revascularization), uncomfortable or intolerable side effects (depression related to beta blockers, bleeding secondary to warfarin), and high cost of care for treatments that may be unnecessary (implantation of a defibrillator in a young adult with an undocumented genetic disease such as Familial Long QT Syndrome). Transgenomic, Inc. is applying its expertise to discovering biomarkers that will enable better management decisions relating to pharmaceutical prescription and other management decisions.
Examples: Warfarin
More than two million Americans take warfarin to prevent blood clotting after cardiovascular events such as heart attack and stroke, and for prophylaxis of clot formation in the setting of major surgery. Despite its popularity and well-established efficacy, warfarin dosing for an intended therapeutic outcome remains challenging as this drug poses significant risks and can have serious side effects including life-threatening bleeding. The optimal maintenance dose of warfarin for each patient is difficult to predict at the beginning of the treatment and it can take a month or more of frequent monitoring of the prothrombin time (PT, a test for blood coagulability) before a stable maintenance dose of warfarin is identified.
Changes in the PT may not always reflect actual response only to warfarin as diet, concomitant medication and environmental factors can influence the PT test results. Genetic tests based on the pharmacokinetic and pharmacodynamic properties of warfarin, on the other hand, are immune to the effects of such external factors and can be accurate predictors of a patient’s response to warfarin. Transgenomic, Inc. has applied its expertise to develop a Therapeutic Diagnostic to help guide physicians in the initial and ongoing dosing of warfarin, which should minimize the time-consuming dose-response monitoring procedures and reduce the risks associated with trial-and-error dosing. Initially, it is our hope that our Warfarin Test provide clinicians with an understanding of how individual patients will respond to warfarin so the initial dosing will be more in line with the patient’s optimal dosing range. |
For more information on Transgenomic's biomarker development program, or the FAMILION family of genetic tests, please click our e-mail link info@familion.com.
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