January 2024—The Genomadix Cube CYP2C19 system is a PCR-based test that provides genotyping results of the *2, *3, and *17 alleles of the CYP2C19 gene from a buccal swab sample in one hour. The system is FDA 510(k) cleared for moderately complex use and can be used in a hospital laboratory or at a satellite testing site.
The compact 4- × 4-inch instrument runs one sample at a time and comes with a dedicated laptop with instrument software. No sample preparation steps or calibration are required and internal controls are built in. The company says the test was 99.1 percent accurate in a method comparison study.
The rapid results enable clinicians to implement CYP2C19 genotyping into a personalized dual antiplatelet therapy strategy aligned with clinical guidelines for patients with loss of function alleles.
Genomadix, 613-228-7756