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Genelex CLIA DNA Test Approved by New York

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Genelex today said that New York state has approved its CLIA-based DNA Drug Sensitivity Tests for the testing of three enzymes involved in drug metabolism.

The approval means Genelex's CLIA lab has regulatory approval to test patient samples from every state in the US, "a critical milestone for Genelex," the company said in a statement.

The test is for three enzymes, the cytochrome P450s, which process more than half of the most commonly prescribed medicines. According to Genelex, research indicates that most patients have one or more defects in the genetic coding of these enzymes, increasing the chances of adverse, sometimes life-threatening, side effects, or non-response to the therapies.

In a statement, Howard Coleman, CEO of Seattle-based Genelex, said the approval by the New York State Department of Health has particular implications for patients who do not respond to the anti-coagulant drug Plavix, generically known as clopidogrel. The company's test for Plavix response, the Plavistest DNA test, identifies these patients, "allowing doctors to personalized treatments and reduce the risks of recurrent heart attack, stroke, or cardiovascular risks," Coleman said.

Earlier this year, the US Food and Drug Administration issued a black box warning on Plavix's label saying that some patients may have diminished function of the CYP2C19 enzyme, resulting in poor metabolism of the drug. The agency further said that doctors may consider genetically testing a patient for this before prescribing Plavix or consider other treatments.

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