August 14, 2012
Spartan Bioscience, the leader in point-of-care DNA testing, today announced that it has achieved ISO 13485 certification for its quality management system. ISO 13485 is an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices.
ISO certification is often considered a first step toward complying with FDA regulatory requirements for a device to be cleared for use in the clinic. Spartan Bioscience is working towards FDA 510(k) clearance in the United States for the Spartan RX CYP2C19—the first point-of-care DNA testing system in medicine.(1) The system has already received CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark.
This ISO 13485 certification covers Spartan Bioscience’s R&D and manufacturing facilities in Ottawa, Canada. The achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of Spartan Bioscience’s products, as well as the company's commitment to continuous improvement.
“Achieving ISO 13485 certification is a major milestone for Spartan,” said Paul Lem, M.D., CEO of Spartan Bioscience. “It is an important step toward bringing point-of-care DNA tests to doctors and patients.”
About the Spartan RX CYP2C19
The Spartan RX CYP2C19 is a 1-hour bedside DNA test that identifies carriers of the CYP2C19*2 gene. This gene is carried by approximately 30 percent of the world’s population.(2) Genetic carriers who receive 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.(3) Currently, genetic testing is performed in central labs and it takes up to seven days to get a test result back. A rapid test is needed because most of the complications for CYP2C19 carriers occur in the first 24 to 48 hours.(3,4) In March 2010, the FDA issued a warning for Plavix® regarding CYP2C19 poor metabolizers. The Spartan RX CYP2C19 has CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark. Spartan Bioscience is working towards FDA 510(k) clearance in the United States. For more information, please visit our website at: http://www.spartanbio.com/products/spartan-rx
About Spartan Bioscience
Spartan Bioscience is the leader in point-of-care DNA testing. The Spartan RX is the first point-of-care DNA testing system in medicine.(1) It is a fully integrated DNA collection, extraction, and analysis platform, with an intuitive interface that is easy to operate—no laboratory training required. For the first time, healthcare providers and their patients can get DNA results on demand. For more information, please visit our website at: http://www.spartanbio.com.
The Spartan logo is a registered trademark of Spartan Bioscience Inc.
Plavix is a registered trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals.
1...For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/8/prweb9788743.htm