Landmark clinical trial begins for rapid DNA testing and personalized anti-blood clotting drugs.
Ottawa, Ontario (PRWEB) December 20, 2012
Spartan Bioscience today announced the start of a 5,945-patient study of personalized medicine for cardiac stent patients. The study is sponsored by the Center for Individualized Medicine at Mayo Clinic and is entitled “Tailored Antiplatelet Initiation to Lessen Outcomes due to Clopidogrel Resistance after Percutaneous Coronary Intervention (TAILOR-PCI).”
This clinical trial will evaluate whether genotyping of cardiac stent patients at the time of angioplasty can help improve patient outcomes by informing providers about drug selection of either Brilinta® (ticagrelor) or Plavix® (clopidogrel). These antiplatelet drugs are prescribed after surgery to reduce clotting complications, such as heart attacks, strokes, and cardiovascular deaths. The drugs are thought to work differently in patients with specific variations in the CYP2C19 gene, and the Spartan RX CYP2C19 rapid DNA testing system will be used to identify these variations in some patients of the TAILOR-PCI study. The study will enroll patients over a 22-month period at 9 hospitals in Canada and the United States.
The principal investigator of the TAILOR-PCI study is Naveen Pereira, M.D., a Mayo Clinic cardiologist. Chiranjit Rihal, M.D., chairman of the Division of Cardiovascular Diseases at Mayo Clinic in Rochester, Minnesota, serves as chairman of the TAILOR-PCI steering committee. The Mayo Clinic sites are Rochester; Jacksonville, Florida; Phoenix, Arizona; and the Mayo Clinic Health Systems in La Crosse, Wisconsin; and Mankato, Minnesota. Canadian sites participating in this study are St. Michael’s Hospital, Toronto General Hospital, Sunnybrook Hospital, and the University of Ottawa Heart Institute.
“We are excited to work with Mayo Clinic on this landmark clinical trial,” said Paul Lem, M.D., CEO of Spartan Bioscience. “Rapid DNA testing means doctors and patients do not have to wait days or weeks for results from a central lab.”
About the Spartan RX CYP2C19
The Spartan RX CYP2C19 is the first point-of-care DNA test in medicine.(1) It identifies carriers of certain 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.
Brilinta is a registered trademark of AstraZeneca.
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.
Paul Lem, M.D.
Spartan Bioscience Inc.
+1 (613) 228-7756 735
Email Information
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Spartan Bioscience Announces 6,000-Patient Study of Personalized Medicine for Cardiac Stents
