Spartan Bioscience Inc., a privately held molecular diagnostics company that develops, manufactures, and markets DNA testing systems for on-demand applications, today announced its Spartan RX CYP2C19 received a CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices. The CE Mark certification allows commercial distribution in Europe as well as in all countries recognizing the CE Mark in the Middle East, Africa, Latin America, and Asia-Pacific regions.
“With the CE IVD Mark certification, European clinicians and cardiologists can now use the proven Spartan RX CYP2C19 to determine their treatment strategy at the onset of heart attacks.”
The Spartan RX CYP2C19 is a non-invasive and easy-to-use DNA testing system that enables physicians to tailor treatments based on a patient's genotype faster than ever before. It 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. Gene carriers who receive the standard dose of Plavix following a cardiac stent insertion to open clogged arteries have a 42 percent higher risk of death, stroke, or heart attack in the first year compared to non-carriers. Current genetic testing for Plavix non-response is performed in central labs and it takes up to seven days to get a test result back, which is often too late because most of the complications for CYP2C19*2 carriers occur in the first 24 to 48 hours. The Spartan RX CYP2C19 test provides automated genotype results in one hour, helping cardiologists determine their anti-blood clotting treatment strategy at the onset of heart attacks. For more information about the Spartan RX CYP2C19, please visit: http://www.spartanbio.com/products/spartan-rx/.
"Since the CYP2C19*2 mutation is found in up to 30 percent of the world's population, it is imperative for labs around the world to have a point-of-care test that can help identify this mutation," said Larry D'Andrea, CEO of Spartan Bioscience. "With the CE IVD Mark certification, European clinicians and cardiologists can now use the proven Spartan RX CYP2C19 to determine their treatment strategy at the onset of heart attacks."
SOURCE Spartan Bioscience