Spartan RX CYP2C19 from Spartan Bioscience Inc, a privately held molecular diagnostics company that develops, manufactures, and markets DNA testing systems for on-demand applications, 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.
The Spartan RX CYP2C19 is a noninvasive DNA testing system that enables physicians to tailor treatments based on a patient’s genotype. 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. 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.
“Since the CYP2C19*2 mutation is found in up to 30% 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