GENOMADIX ANNOUNCES FDA CLEARANCE TO MARKET THE GENOMADIX CUBE CYP2C19 SYSTEM
(OTTAWA, March 22, 2023) 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” (CubeTM CYP2C19 Test), an automated sample-to-result PCR test.
The CubeTM CYP2C19 Test is indicated as an aid for clinicians to determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. The CubeTM CYP2C19 Test identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a non-invasive buccal swab in 1 hour.
“The Genomadix CubeTM 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 adding to our already European CE-IVD marked CYP2C19 test. Genomadix is excited to commence precision medicine commercialization activities in the United States.”
The Genomadix CubeTM is a PCR molecular diagnostics platform capable of performing tests for genetic, infectious disease and environmental targets on a sample-to-result platform. The system’s portable size, ease of use, and on-demand processing capability enables users to generate time-critical results in a near-patient setting.
The CYP2C19 enzyme plays a role in metabolizing at least 10% of current clinically used drugs including anti-platelet medication, antidepressants, and proton pump inhibitors.1,2 Genetic variability of CYP2C19 can affect the clinical effectiveness and safety of these drugs.2 Approximately 3 in 10 people carry high risk mutations that can impair the function of affected drugs.1
About Genomadix, Inc.
Genomadix Inc. is a pioneer in real-time RT-PCR point of use technology, dedicated to the highest level of customer satisfaction, quality, and support, maintaining ISO 13485 medical device development and manufacturing standards certification. Based in Ottawa, Canada, the Genomadix CubeTM automates complex and tedious manual procedures, advancing sample to result DNA/RNA testing in clinical, environmental, infectious disease, and precision medicine. For more information, visit www.genomadix.com.
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- Biswas M. Global distribution of CYP2C19 risk phenotypes affecting safety and effectiveness of medications. Pharmacogenomics J. 2021 Apr;21(2):190-199. doi: 10.1038/41397-020-00196-3. Epub 2020 Oct 20. PMID: 33082528.
- Zanger UM, Schwab M. Cytochrome P450 enzymes in drug metabolism: regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacol Ther. 2013;138:103–41. doi.org: 10.1016/j.pharmthera.2012.12.007
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