Spartan Bioscience receives FDA clearance for rapid DNA test of mutations affecting drug metabolism

Spartan Bioscience has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Spartan RX CYP2C19 System. The test provides genetic results in less than 60 minutes from a non-invasive cheek swab.

The automated system is indicated as an aid for clinicians to determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. These include some of the world’s most commonly prescribed drugs such as Plavix (clopidogrel), Inderal (propranolol), Celexa (citalopram), and Losec (omeprazole). The sample-to-result system identifies CYP2C19*2, *3, and *17 variations from a patient’s cheek swab. Spartan representatives say that the system’s ease of use and on-demand processing capability enable hospitals to generate time-critical results.

The CYP2C19 enzyme metabolizes approximately 15% of all prescribed drugs, including important drug classes such as anti-platelet therapies (clopidogrel), beta blockers (propranolol), anti-depressants (citalopram), proton pump inhibitors (omeprazole), and anti-epileptics (phenytoin). 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 (2,3,4,5). The CYP2C19*2 and *3 variants account for the majority of reduced drug metabolism. The CYP2C19*17 variant is associated with increased drug metabolism.

“The Spartan RX CYP2C19 System helps doctors treat patients faster with the most effective drugs,” says Paul Lem, MD, CEO of Spartan Bioscience. “FDA clearance is a significant achievement for Spartan Bioscience. There is a tremendous opportunity for rapid DNA testing in the United States.” Learn more about the Spartan RX CYP2C19 System from the company’s website.