Spartan Bioscience Announces CE Marking for First Point-of-Care DNA Personalized Medicine Testing System
The CE Mark allows the Spartan RX CYP2C19 to be distributed in select countries across Europe, Middle East, Africa, Latin America, and Asia Pacific. The Spartan RX CYP2C19 designed to help cardiologists determine most effective anti-blood clotting drug and dosage at the onset of heart attacks.
Launched in August 2010, Spartan RX CYP2C19, was designed to help cardiologists identify patients who have a gene mutation that causes impaired metabolism to the popular anti-blood clotting medication Plavix® (clopidogrel), which may lead to major adverse cardiac events. The CYP2C19*2 mutation is found in up to 30% of the population. Individuals with this mutation who receive the standard dose of Plavix following a cardiac stent insertion to open clogged arteries have an 11.7% absolute risk of death, stroke, or heart attack in the first year (compared to 8.3% for non-carriers).
The U.S. Food and Drug Administration issued a warning for Plavix in March 2010. The genotype results provided by the Spartan RX CYP2C19 test will help determine the most effective anti-blood clotting drug and dosage at the onset of heart attacks.
“Currently, genetic testing for Plavix non-response is performed in central labs and it takes one to seven days to get a test result back. This is often too late because most of the complications for CYP2C19*2 carriers occur in the first 24 to 48 hours,” said Derek So, M.D., staff cardiologist, University of Ottawa Heart Institute. “As a one-hour point-of-care test, the Spartan RX CYP2C19 has the potential to significantly reduce major cardiac events in heart attack patients.”
“The long-term trend for DNA testing is to move from the central lab to point-of-care,” said Paul Lem, M.D., founder of Spartan Bioscience. “Spartan has turned this prediction into reality by creating a fully integrated DNA collection, extraction and analysis platform, and adding an intuitive interface that can be operated by nurses and other non-technical users.”
The Spartan RX System and Spartan RX CYP2C19 test are currently available for investigational testing. At the University of Ottawa Heart Institute, Dr. So is using the testing system to run the RAPID GENE study, a prospective randomized clinical trial, which will determine if alternative anti-blood clotting therapy with Effient® (prasugrel) for CYP2C19*2 carriers reduces major adverse cardiovascular events.
In October 2010, Spartan Bioscience was named as one of Canada’s Top 10™
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