Medical Laboratory and Biomedical Science: First Point-of-Care DNA Test Submitted for FDA Clearance by Spartan Bioscience

Friday, April 5, 2013

First Point-of-Care DNA Test Submitted for FDA Clearance by Spartan Bioscience

Spartan Bioscience, a point-of-care DNA testing company, has announced that it has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its Spartan RX CYP2C19 genetic test.

CYP2C19 is an enzyme that metabolizes commonly-prescribed drugs, including antiarrhythmics, proton pump inhibitors, antidepressants, and antiplatelet drugs. About 30% of Caucasians, 40% of Africans, and more than 50% of Asians and Indians carry CYP2C19 gene variants that reduce response to drugs metabolized by CYP2C19.(1,2,3,4)