Genomadix’s Cube CYP2C19 system gets FDA nod

Genomadix, based in Ottawa, Canada, announced today the US Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of its “Genomadix CubeTM CYP2C19 System” (Cube CYP2C19 test), an automated sample-to-result PCR test.

The Cube CYP2C19 test can be used to aid clinicians in determining therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. Genomadix Cube CYP2C19 System identifies the CYP2C19 *2, *3, and *17 alleles, if present, directly from buccal swab in about an hour.

“The Genomadix Cube CYP2C19 System empowers physicians to make informed decisions on appropriate drug selection for a number of precision medicine indications such as antiplatelet therapy in both stroke and cardiology patients,” said Steve Edgett, Genomadix’s Chief Executive Officer. “This achievement represents a milestone for Genomadix. Genomadix is excited to commence precision medicine commercialization activities in the United States.”

The Genomadix Cube is a polymerase chain reaction (PCR) molecular diagnostic instrument capable of performing tests for genetic, infectious disease, and environmental targets on a sample-to-result platform. The portable size, ease of use, and on-demand processing capability enables users to generate time-critical results.

The Genomadix Cube CYP2C19 System is commercially distributed in Europe, as well as all countries recognizing the CE Mark (CE-IVD).
MB Bureau