Genomadix Inc. Announces Health Canada License for Rapid Genetic Test to Aid Therapy Selection for Stroke and Cardiovascular Disease Patients

OTTAWA, CANADA, January 30,2025 – Genomadix (genomadix.com), a global leader in point of need precision medicine diagnostics, announced today that they have received a medical device licence (MDL) from Health Canada 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 CubeTM CYP2C19 System identifies the CYP2C19 *2, *3, and *17 alleles, if present, directly from buccal swabs in about an hour.

Dr Chad Bousman, MPH, PhD, an associate professor of Medical Genetics, Psychiatry, Physiology & Pharmacology, and Community Health Sciences at the University of Calgary, stated “Rapid CYP2C19 genotyping is crucial for Canadian stroke patients, as it enables personalized antiplatelet therapy, improving treatment efficacy and reducing the risk of recurrent strokes.” Dr. Bousman is conducting a study at his facility evaluating the implementation of Genomadix’s CYP2C19 test for clinical use.

“We are extremely pleased to now have Health Canada approval for the Genomadix CubeTM CYP2C19 testing system, adding to our European CE-mark and US FDA clearance.” said Genomadix’s CEO, Steve Edgett. “This enables Genomadix to support the introduction of this novel testing into clinical application at Canadian medical centres where we are honoured to aid clinicians with rapid CYP2C19 genetic testing results.  Such testing can aid in the reduction of medical costs and improve outcomes for patients suffering from stroke or undergoing stenting procedures related to cardiovascular disease.”1

Genomadix’s Canadian MDL listing can be found here.

1. Pereira et al., Circulation. 2024;150:e129–e150.

About Genomadix

Based in Ottawa, Canada, Genomadix Inc. is a pioneer in real-time qPCR point of need technology. The Genomadix Cube is a molecular diagnostic instrument capable of performing tests for precision medicine genotyping on a sample-to-result platform. The portable size, ease of use, and on-demand processing capability enables users to generate time-critical results in approximately one hour. The Cube platform is also available as an open platform (CubeX) that can be used to design, develop and run any qPCR test for research or product development purpose. Applications of the Genomadix Cube technology include, but are not limited to, precision medicine, clinical diagnostics and environmental testing. For more information, visit www.genomadix.com.

Media contact: Tara Linseman, Sr. Manager of Product Management

media@genomadix.com   +1-613-228-7756

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