Health Canada approves AutoGenomics’ INFINITI PGx testing system

AutoGenomics, a leader in providing automated, molecular microarray testing solutions, announced today that they have received their first Health Canada Medical Device Class III approvals for their automated INFINITI Pharmacogenomic (PGx) testing system. These initial approvals include the INFINITI instrument plus two thrombolytic drug metabolism related test kits, and will provide patient access to individualized therapeutic management strategies by determining the individual's drug metabolism rate which is strongly related to their genetic profile. The Warfarin Assay identifies individuals at risk for sensitivity to Warfarin (Coumadin), a widely used anticoagulant. The 2C19 Assay indicates how a patient will metabolize commonly prescribed drugs, including antidepressants, antiepileptics, barbiturates, proton pump inhibitors, and their potential therapeutic effects.

"This is the beginning of a new era for us in Canada as we begin 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. We wish to enable easy access of these powerful genetic testing results by regional healthcare agencies and physicians across Canada," said Mr. Fareed Kureshy, President and CEO of AutoGenomics. He further said that "with increasing demands for alternative technologies to meet the evolving need for genotyping we are excited that we can offer an automated solution which significantly enhances workflow efficiency in the laboratory."

"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," said Laurel Wiseman, President of ESBE Scientific, Markham, Ontario - Authorized AutoGenomics Canadian Systems Distributor.