The New York State Department of Health has licensed Genelex Corporation’s DNA Drug Sensitivity Tests for use by doctors in the state. The issued Clinical Laboratory Permit is for DNA testing of three enzymes, the cytochrome P450s, that process more than 50 percent of the most commonly prescribed medicines. Research shows the majority of patients have one or more defects in the genetic coding for these enzymes, greatly increasing their risk of treatment failure or potentially life-threatening, adverse side effects.
“This is an important advance for personalized medicine in New York, especially for the 100,000 or more patients who live there and are failing their Plavix treatment,” said Howard Coleman, CEO, Genelex. “The Plavitest™ DNA test identifies these at-risk patients, allowing doctors to personalize treatments and reduce the risks of recurrent heart attack, stroke or other cardiovascular risks.” Coleman added that these assertions are based on a series of large clinical studies that led the US Food and Drug Administration to add a boxed warning to the Plavix label. A boxed warning requires physicians to take described risks into account when planning treatments. Similar genetic risks apply to many other important drugs used to treat cardiovascular disease, cancer, pain and mental conditions. These risks are exacerbated disproportionately in the elderly because of the many drugs they take and their already diminished drug processing capacity.
Earning the New York State Permit required Genelex to successfully complete a comprehensive evaluation considered the most rigorous in the United States. The evaluation program included on-site inspections, proficiency testing, and assessment of personnel qualifications to ensure the accuracy and reliability of laboratory test results. According to Dr. Tia Aulinskas, Genelex laboratory director, the company now has all required state clinical laboratory licenses in the U.S. and can receive and test specimens from every state–a critical milestone for Genelex.
SOURCE Genelex Corporation