For the first time in medicine, nurses were able to perform DNA testing at the patient’s bedside.
-Derek So, M.D., University of Ottawa Heart Institute
Ottawa, Ontario (PRWEB) March 29, 2012
Spartan Bioscience today announced publication in Lancet of clinical results from the world’s first bedside DNA test. The paper, "Point-of-care genetic testing for personalization of antiplatelet treatment (RAPID GENE)", reports on the use of the Spartan RX CYP2C19, a simple cheek swab test performed by nurses at the patient’s bedside. It allowed doctors to rapidly identify patients with a genetic variant known as CYP2C19*2. Cardiac stent patients with this variant are at risk of reacting poorly to standard antiplatelet therapy with Plavix® (clopidogrel). The study demonstrated that drug therapy tailored to patients’ genetics completely eliminated poor response to treatment. The research was conducted by researchers from the University of Ottawa Heart Institute, Canada’s largest cardiovascular health centre.
The CYP2C19*2 gene is carried by approximately 30% of Caucasians, 50% of Asians, and 55% of East Indians.(1,2,3,4) 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.(5) Over 1 million cardiac stent procedures are performed annually in the United States.(1) Following this procedure, patients are typically prescribed clopidogrel for one year or more. In 2009, Plavix® was the second best-selling drug in the world, with over $9 billion in revenues.
The RAPID GENE study enrolled 200 patients who were being treated with cardiac stenting for an acute coronary syndrome or stable angina. Patients were randomized to a treatment strategy of rapid point-of-care genotyping and Effient® (prasugrel) for CYP2C19*2 carriers, or to standard therapy with Plavix® (clopidogrel). The Spartan RX CYP2C19 bedside DNA test was performed by nurses who received a 30-minute training session, but had no prior laboratory training. The test had a sensitivity of 100% and a specificity of 99.4% compared with DNA sequencing. For CYP2C19*2 carriers, treatment with prasugrel completely eliminated High on-treatment Platelet Reactivity (HPR). HPR is a marker for patients at risk of complications after stenting. In contrast, 30.4% of carriers receiving clopidogrel had HPR at 1 week.
“For the first time in medicine, nurses were able to perform DNA testing at the patient’s bedside. This is a significant step towards the vision of personalized medicine,” said Derek So, M.D., F.R.C.P., Interventional Cardiologist at the University of Ottawa Heart Institute (UOHI), and principal investigator of the RAPID GENE study.
"For years, experts have been predicting that DNA testing has the potential to revolutionize medicine,” said Larry D’Andrea, CEO, Spartan Bioscience. “The future is finally here. Bedside DNA testing is now a reality.”
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.(1) 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.(5) 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.(5,6) 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.
Effient is a registered trademark of Eli Lilly and Company.
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2. Chen M et al. (2011). Atherosclerosis. 220(1):168–71.
3. Oh IY et al. (2012). Heart. 98(2):139–44.
4. Jose R et al. (2004). Fundamental & Clinical Pharmacology. 19(1): 101–105.
5. Mega JL et al. (2009). N Engl J Med. 360:354–62.
6. Wiviott SD et al. (2007). N Engl J Med. 357:2001–2015.