Spartan Bioscience Receives FDA Clearance for First Rapid DNA Test of Mutations Affecting Metabolism of Common Drugs
Spartan Bioscience today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of the Spartan RX CYP2C19 System. It 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. The system’s ease of use and on-demand processing capability enable hospitals to generate time-critical results.
“The Spartan RX CYP2C19 System helps doctors treat patients faster with the most effective drugs,” said Paul Lem, M.D., 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.”
About CYP2C19
The CYP2C19 enzyme metabolizes approximately 15 percent 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).(1) About 30 percent of Caucasians, 40 percent of Africans, and more than 50 percent 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.
About Spartan Bioscience
Spartan Bioscience is the leader in on-demand DNA testing.(6) In the same way that mainframe computers gave way to personal computers, high-throughput DNA testing systems in central labs are giving way to decentralized devices. Stop waiting days to weeks—get results on demand with Spartan. For more information, please visit our website at: https://www.spartanbio.com.
The Spartan logo is a registered trademark of Spartan Bioscience Inc.
Plavix is a registered trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals.
Inderal and Losec are registered trademarks of AstraZeneca.
Celexa is a registered trademark of Forest Pharmaceuticals.
