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Biomarker Development CV
PGxHealth’s 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, oncology. Once the genetic marker is known, and clinical utility is evident, PGxHealth has the experience to validate and commercialize genetic tests based on these markers. The genetic markers that are developed and included in PGxHealth’s test catalog are chosen for commercialization based PGxHealth’s assessment of their economic and clinical value to the key consumers of these tests (including patients, providers, payers). In addition, we work directly with those developing therapeutics to identify genetic markers, incorporate the markers into their commercialization plan, and PGxHealth is positioned to commercialize the resultant genetic tests for our clients as well in the same manner we commercialize our own genetic tests. PGxHealth 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, 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 for cardiovascular diseases. Current treatment 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 unnecessary treatments (implantation of a defibrillator in a young adult with an undocumented genetic disease such as Familial Long QT Syndrome). Clinical Data is applying its expertise to discovering genetic markers that will enable better targeting of medications such as warfarin and devices such as defibrillators to patients who will benefit most.
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. PGxHealth is applying 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 the availability of our new Warfarin Test, please click our e-mail link info@PGxHealth.com.
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