The approval will enable bioLytical Laboratories to sell iStatis Covid-19 antigen test across Canada for professional use in point-of-care settings
The test kits will be manufactured in bioLytical’s facility in Richmond, British Columbia. (Credit: GlobeNewswire, Inc./bioLytical Laboratories Inc.)
Diagnostic device manufacturer bioLytical Laboratories has secured Health Canada’s approval for its iStatis Covid-19 antigen test.
The approval will enable the company to sell the Covid-19 antigen test across Canada for professional use in point-of-care settings.
Built on bioLytical’s INSTI testing platform, the test allows for greater portability and can be performed in a multitude of settings with easy-to-understand results.
The firm claims that the performance of the test in clinical studies demonstrated high accuracy, with industry-leading sensitivity and specificity.
The company said that iStatis test is aimed at providing reliable access to testing and reaching more people.
bioLytical CEO Rob Mackie said: “We are excited to announce the addition of iStatis with our new Covid-19 rapid antigen test.
“With this new platform, we are able to expand our reach, creating more equitable access to testing. With the scarcity of available antigen tests, we saw an opportunity to ensure that Canadians have a reliable test they can trust.”
The test kits will be manufactured in bioLytical’s MDSAP and ISO 13485-certified facility in Richmond, British Columbia, to sell and distribute across Canada.
In October 2020, bioLytical Laboratories launched a new one-minute antibody test for Covid-19 in Europe.
Based in Canada, bioLytical is focused on the research, development, and commercialisation of rapid in-vitro medical diagnostics levering its Insti technology platform and its lateral flow line, iStatis.