On 6 December, Spartan Bioscience announced the start of GENE-MATRIX—the largest clinical trial to date of point-of-care DNA testing in medicine.
The randomised prospective trial will enrol 4,000 patients over two years at up to 40 hospitals in Italy. The Spartan RX CYP2C19 point-of-care DNA testing system will be used to test heart attack patients receiving cardiac stents. Genetic carriers will receive personalised antiplatelet therapy with clopidogrel (Plavix) or alternative medications such as prasugrel (Effient) and ticagrelor (Brilinta). This landmark study will measure hard clinical endpoints at one year such as cardiovascular death, myocardial infarction, stroke, and bleeding.
“The GENE-MATRIX study will help us determine the best method for managing antiplatelet therapy in cardiac stent patients,” said Marco Valgimigli, director of the Catheterization Laboratory at the University Hospital of Ferrara, Italy, and principal investigator of the study. “Spartan’s point-of-care technology is the key to making this study happen. It would not have been practical to send samples to a central lab and wait weeks for a result.”
GENE-MATRIX is a genetic substudy of the MATRIX clinical trial which sponsored by the Gruppo Italiano Studi Emodinamica (GISE) with unrestricted grants from The Medicines Company and Terumo. MATRIX is a randomised prospective trial of approximately 7,000 acute coronary syndrome patients undergoing trans-radial versus trans-femoral cardiac stenting. Patients will be randomised to receive either bivalirudin or unfractionated heparin with or without glycoprotein IIb/IIIa inhibitors.
About the Spartan RX CYP2C19
The Spartan RX CYP2C19 is a 1-hour point-of-care genetic test that identifies carriers of the CYP2C19*2 gene. This gene is carried by approximately 30% of the world’s population (Damani et al, J Am Coll Cardiol. 2010; 56:109–11). Genetic carriers who receive Plavix following a cardiac stent insertion to open clogged arteries have a 42% higher risk of death, stroke, or heart attack in the first year compared to non-carriers (Mega et al, N Engl J Med. 2009; 360:354–62). 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. In March 2010, the FDA issued a warning for Plavix regarding CYP2C19 poor metabolisers. The Spartan RX CYP2C19 has CE IVD mark regulatory approval for Europe and other countries recognising the CE IVD mark. Spartan Bioscience is working towards FDA 510(k) clearance in the United States.