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Spartan Bioscience RX CYP2C19 wins CE IVD mark

Spartan Bioscience, a privately held molecular diagnostics company that develops, manufactures and markets DNA testing systems for on-demand applications, has received CE IVD mark for its RX CYP2C19, 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.

Spartan said 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.

The 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).

The test provides automated genotype results in one hour, helping cardiologists determine their anti-blood clotting treatment strategy at the onset of heart attacks.

Spartan Bioscience CEO Larry D’Andrea said 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.

"With the CE IVD Mark certification, European clinicians and cardiologists can use the proven Spartan RX CYP2C19 to determine their treatment strategy at the onset of heart attacks," Andrea said.