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AutoGenomics Gets Health Canada OK for PGx System

NEW YORK (GenomeWeb News) – Autogenomics today said that it has received regulatory approval in Canada to market its Infiniti Pharmacogenomic testing system.

The Vista, Calif.-based firm received Health Canada Medical Device Class III approvals for the system along with two thrombolytic drug metabolism test kits, one for warfarin sensitivity and the other a 2C19 assay that indicates how a patient will metabolize commonly prescribed drugs.

The system and tests will be distributed in Canada by ESBE Scientific to labs providing clinical molecular testing services.

Autogenomics received US Food and Drug Administration clearance to market its Infiniti 2C9-VKORC1 Multiplex Assay for warfarin sensitivity in early 2008. It received FDA clearance for the Infiniti CYP2C19 assay in 2010.

The Scan

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