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Genomadix Gets FDA 510(k) Clearance for PCR System, CYP2C19 Test

NEW YORK – Genomadix announced on Wednesday that the US Food and Drug Administration has granted 510(k) clearance to its automated sample-to-result Genomadix Cube PCR system and CYP2C19 test.

The Cube and CYP2C19 test can identify the CYP2C19 *2, *3, and *17 alleles directly from a buccal swab in about one hour, the Ottawa, Canada-based firm, formerly known as Spartan Bioscience, said in a statement.

The CYP2C19 test can be used to aid clinicians in determining therapeutic strategies for drugs metabolized by the CYP450 2C19 genetic pathway.

"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," Steve Edgett, Genomadix's CEO, said in the statement.

The Cube molecular diagnostic instrument can perform tests for genetic, infectious disease, and environmental targets, the firm said, noting that it is portable, easy to use, and features on-demand processing to allow users to quickly generate results.

The CYP2C19 enzyme plays a role in metabolizing at least 10 percent of drugs used in clinical settings, including anti-platelet medication, antidepressants, and proton pump inhibitors, Genomadix said. Genetic variability of CYP2C19 can affect the clinical effectiveness and safety of these drugs, with approximately three in 10 people carrying high-risk mutations that can impair the function of medication.

Genomadix entered a collaboration with the Mayo Clinic to advance the Cube system last year, and it is also being assessed by the UK National Institute for Health and Care Excellence (NICE).

The system is currently commercially distributed in Europe and all countries recognizing the CE mark. The FDA clearance "represents a milestone" for Genomadix, Edgett said, adding that the firm is "excited to commence precision medicine commercialization activities in the US."