The FDA has granted Spartan Bioscience, Ottowa, 510(k) clearance for the Spartan RX CYP2C19 System, which provides genetic results in less than 60 minutes from a noninvasive cheek swab.
The automated system aids clinicians in determining a 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. Its ease of use and on-demand processing capability enable hospitals to generate time-critical results.
The CYP2C19 enzyme metabolizes about 15% of all prescribed drugs, including important drug classes such as antiplatelet therapies (clopidogrel), beta blockers (propranolol), antidepressants (citalopram), proton pump inhibitors (omeprazole), and antiepileptics (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, the company says. The CYP2C19*2 and *3 variants account for the majority of reduced drug metabolism. The CYP2C19*17 variant is associated with increased drug metabolism.
[Source: Spartan Bioscience]