This article has been updated to clarify that the test has not been cleared for use in a point-of-care setting.
NEW YORK (GenomeWeb News) – Canadian molecular diagnostics developer Spartan Bioscience said today that the US Food and Drug Administration has granted 510(k) clearance to the Spartan RX CYP2C19 assay.
Spartan RX CYP2C19 is indicated for use as an aid to clinicians in determining strategies for therapeutics that are metabolized by the cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles, according to the FDA.
The test can identify these CYP2C19 variations from a patient's cheek swab in less than an hour with minimal intervention by a laboratory technician, according to Ottawa-based Spartan Bio. An FDA spokesperson told GenomeWeb Daily News that the device must be used in a clinical lab and is not cleared for point-of-care use.
The CYP2C19 enzyme metabolizes approximately 15 percent of all prescribed drugs, including drug classes such as anti-platelet therapies, beta blockers, anti-depressants, proton pump inhibitors, and anti-epileptics. Specific examples of commonly prescribed drugs in these categories include clopidogrel, marketed as Plavix by Bristol-Myers Squibb/Sanofi; propranolol, marketed as Inderal by AstraZeneca; and citalopram, marketed as Celexa by Forest Pharmaceuticals.
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 the gene product. The CYP2C19 *2 and *3 variants account for the majority of reduced drug metabolism, while the *17 variant is associated with increased drug metabolism.
The Spartan RX CYP2C19 assay is not indicated for prediction of drug response or non-response, the FDA said in its letter.
The assay received CE marking for in vitro diagnostic use in December 2010. Since that time, Spartan has signed on several distributors for the test in Europe, including Germany's Alere.
In December, Spartan announced the commencement of a 5,945-patient trial to study the use of Spartan RX CYP2C19 for personalized therapy in cardiac stent patients.
The study, sponsored by the Center for Individualized Medicine at the Mayo Clinic, is entitled "Tailored Antiplatelet Initiation to Lessen Outcomes due to Clopidogrel Resistance after Percutaneous Coronary Intervention." It will evaluate whether genotyping cardiac stent patients at the time of angioplasty can help improve patient outcomes by informing providers about drug selection of either Plavix or ticagrelor, marketed by AstraZeneca as Brilinta.