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CMS Approves Iverson Clinical Study of Genetic Testing for Warfarin

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Iverson Genetic Diagnostics said on Monday that it has received approval from the federal agency overseeing Medicare to conduct a clinical study to determine the effect of a genetic test on warfarin dosing.

The two-year study, approved by the Centers for Medicare & Medicaid Services, will assess the impact of genetic information on determining warfarin dosage and changes in the rate of adverse events when beginning a warfarin treatment regimen, Iverson said in a statement. The changes will be compared against doses started without genetic information.

The multi-center study is anticipated to involve more than 7,000 participants at more than 50 sites across the country, the Bothell, Wash.-based company said.

The approval from CMS is for a clinical study under Coverage with Evidence Development and will cover pharmacogenomic testing of CYP2C9 or VKORC1 alleles for their ability to predict warfarin responsiveness. Research has shown that the two genes contribute up to 60 percent of individual patient variations in response to the anticoagulant, Iverson said.

The study will assess changes in warfarin side effects, such as major hemorrhagic or thromboembolic events, when genetic information is used to determine individual warfarin dosing amounts for patients. Iverson said that 1 to 5 percent of the 2 million patients prescribed warfarin in the US experience a major bleeding event, and an estimated $1.1 billion is spent each year as a result of complications from warfarin.

Iverson's study will be led by Elizabeth Ofili, director of clinical research, chief of cardiology, and associate dean for clinical research at the Morehouse School of Medicine in Atlanta, Ga.

The decision by CMS comes a little more than a year after it said that it would not pay for genetic tests to help determine individual dosing levels of warfarin for patients, saying that there was not enough evidence that such tests benefitted Medicare beneficiaries.

In a statement, Iverson CEO Dean Sproles said that CMS' approval of the study "is evidence of the growing role of genetics in helping doctors to develop optimal individual treatments for their patients. The data from this study will contribute to determining if the use of genetics in warfarin dosing reduces adverse health events."

The initiative by Iverson joins other similar efforts aimed at using genetic variation to determine individual warfarin dosing levels. In April, Washington University said it and several other hospitals were conducting a clinical trial investigating the utility of genetic variants to customize warfarin dosing.

Meanwhile, a handful of companies are either developing or marketing warfarin sensitivity tests. Firms who have received FDA clearance for such tests include GenMark, formerly known as Osmetech, TrimGen, Nanosphere, Autogenomics, and Paragon Dx.

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