Spartan Bioscience, Ottowa, a point-of-care DNA testing company, has submitted a 510(k) premarket 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.
“This is an important milestone in Spartan’s growth strategy,” says Paul Lem, MD, CEO, Spartan Bioscience. “The United States is the world’s largest market for genetic testing.”
| The Spartan RX is the first complete sample-to-result, point-of-care DNA testing system in medicine, according to the company. It is a fully integrated DNA collection, extraction, and analysis platform, with an intuitive interface that is easy to operate—no lab training required. |
The test identifies carriers of certain CYP2C19 genetic mutations in 1 hour.
These mutations are carried by approximately 30% of the world’s population.
The Spartan RX CYP2C19 has CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark.
The company is working toward FDA 510(k) clearance in the United States.
[Source: Spartan Bioscience]
