Ottawa, Ontario (PRWEB) January 29, 2013
Spartan Bioscience today announced a distribution agreement with Medial for the Spartan RX—the first point-of-care DNA test in medicine.(1) Medial is a leading provider of medical devices to hospitals in the Czech Republic.
The Spartan RX point-of-care DNA testing system identifies carriers of CYP2C19 loss-of-function mutations, which are carried by approximately 30% of the world’s population.(2) Genetic carriers who receive Plavix® (clopidogrel) following a cardiac stent have a 42 percent higher risk of death, stroke, or heart attack in the first year compared to non-carriers.(3) In 2009, Plavix® was the second best-selling drug in the world, with over $9 billion in revenues.
“Medial has over 20 years of experience in bringing innovative medical devices to the Czech Republic,” said Paul Lem, M.D., CEO of Spartan Bioscience. “We are pleased that Medial will now oversee distribution of the Spartan RX in the Czech market.”
“We have already received significant interest in the Spartan RX from many cardiologists,” said Jan Marek, General Manager of Medial. “We look forward to a long and profitable partnership with Spartan Bioscience.”
About the Spartan RX CYP2C19
The Spartan RX CYP2C19 is the first bedside DNA test in medicine.(1) It identifies carriers of CYP2C19 genetic mutations in 1 hour. These mutations are 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 complete sample-to-result, point-of-care DNA testing system in medicine. 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. Roberts JD et al. (2012). Lancet. 379: 1705–1711.
2. Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–111.
3. Mega JL et al. (2009). N Engl J Med. 360:354–362.
4. Wiviott SD et al. (2007). N Engl J Med. 357:2001–2015.