Health Canada has granted medical device Class III approval to AutoGenomics' new automated microarray-based Infiniti pharmacogenomic (PGx) testing system.
The Infiniti PGx system, including Infiniti instrument, Warfarin and 2C19 test kits, will determine individual's drug metabolism rate related to their genetic profile and provide patient access to individualised therapeutic management strategies.
The Warfarin assay identifies individuals at risk for sensitivity to Warfarin, while the 2C19 assay indicates how a patient will metabolise antidepressants, antiepileptics, barbiturates, proton pump inhibitors drugs and their potential therapeutic effects.
AutoGenomics president and CEO, Fareed Kureshy, said this is the beginning of a new era for the company in Canada as it begins, together with ESBE Scientific, to provide Canadian clinical molecular laboratories with automated, commercially prepared test kits for a variety of PGx testing demands.
"Generating this critical test information is now only possible with time-consuming and technique-dependent sequencing methodologies oriented more to research settings," Kureshy added.
"With increasing demands for alternative technologies to meet the evolving need for genotyping, we are excited that we can offer an automated solution that significantly enhances workflow efficiency in the laboratory."
ESBE Scientific president and AutoGenomics Canadian systems distributor, Laurel Wiseman, said: "We are pleased to deliver these coagulation-related PGx practical DNA test solutions to our Canadian hospital reference laboratory clientele and look forward to expanding this initial Health-Canada-approved test kit menu to include cancer PGx, pain management PGx, along with infectious disease assay solutions."