Automated Sample-to-Result PCR Test Enables Rapid Genotyping for Antiplatelet Therapy

By LabMedica International staff writers
Posted on 27 Mar 2023

Image: The Genomadix Cube CYP2C19 System has been granted FDA 510(k) clearance (Photo courtesy of Genomadix)

The CYP2C19 enzyme plays a critical role in metabolizing approximately 10% of current clinically used medications, including anti-platelet drugs, proton pump inhibitors, and antidepressants. Genetic variability of CYP2C19 can have an impact on the clinical efficacy and safety of these medications. High-risk mutations in approximately 3 in 10 individuals can impair the function of drugs affected by this enzyme. Determining whether a patient is likely to respond favorably to the prescribed medication can enhance healthcare for individuals. The rapid genotyping of CYP2C19 helps physicians select the most effective medications for their patients.

The Genomadix Cube CYP2C19 System (Cube CYP2C19 test), an automated sample-to-result PCR test from Genomadix (Ottawa, Canada), can be used by clinicians to determine the 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 approximately one hour.

The Genomadix Cube is a molecular diagnostic instrument that employs polymerase chain reaction (PCR) technology to test for genetic, infectious disease, and environmental targets using a sample-to-result platform. Its portable size, user-friendly design, and ability to deliver on-demand results enable 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), and has now been granted 510(k) clearance by the US Food and Drug Administration (FDA).

"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."

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