Canada's Spartan Bioscience said this week that it has launched a clinical trial in Italy to evaluate the company's point-of-care CYP2C19 DNA test in guiding antiplatelet therapy in cardiac stent patients.
The randomized prospective trial will enroll 4,000 patients over two years at up to 40 hospitals in Italy, Spartan said. Trial sites will use the Spartan RX CYP2C19 point-of-care DNA testing system to test heart attack patients receiving cardiac stents. Carriers of the CYP2C19*2 mutation will receive personalized antiplatelet therapy with Plavix (clopidogrel) or alternative medications such as Effient (prasugrel) and Brilinta (ticagrelor).
At one year, the study will measure hard clinical endpoints such as cardiovascular death, myocardial infarction, stroke, and bleeding.
The trial, called Gene-MATRIX, is a genetic substudy of the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX) clinical trial, a randomized prospective trial of around 7,000 acute coronary syndrome patients undergoing cardiac stenting.
According to Spartan, Gene-MATRIX will be the largest clinical assessment of a point-of-care DNA testing platform to date. Data from the trial will not be used to support a 510(k) application with the US Food and Drug Administration; however, according to Spartan founder and board member Paul Lem, the trial is expected to be one of the first to "truly demonstrate" whether personalized antiplatelet therapy is effective.
In addition, the trial "has the potential to generate the sort of results that could spur the [American Heart Association] and [European Society of Cardiology] to consider recommending genetic testing for all cardiac stent patients receiving Plavix," Lem said.
Spartan is currently setting up a trial in the US with fewer patients to support an FDA submission for Spartan RX CYP2C19. The company said last month that it hopes to achieve 510(k) clearance by the end of 2012 (PCR Insider, 11/17/11).
Spartan RX is a fully automated, point-of-care PCR-based testing platform that the company claims can complete a genetic test such as the CYP2C19 assay in an hour or less. The company, based in Ottawa, Ontario, obtained the CE IVD Mark for the platform in December 2010 (PCR Insider, 12/23/10).