Spartan Bioscience is becoming a leader in point-of-care DNA testing, with the Spartan RX being the first complete sample-to-result, point-of-care DNA testing system in medicine. Based on the research of the Montreal Heart Institute, the Université de Montreal Beaulieu Saucier Pharmacogenomics Centre and CEPMed, Spartan is seeking FDA approval for the Spartan RX CYP2C19, a 1-hour point-of-care genetic test that identifies carriers of the CYP2C19 gene in 2013.
This gene is carried by approximately 30 percent of the world’s population. Genetic carriers who receive Plavix following a cardiac stent insertion have a 42 percent higher risk of death, stroke, or heart attack in the first year compared to non-carriers. Current genetic testing performed in central labs take up to seven days. A rapid test will significantly reduce complications for poor metabolizers . The Spartan RX CYP2C19 has CE IVD Mark regulatory approval for Europe and the approval of the FDA.