bioLytical Laboratories Inc. Receives Health Canada Authorization for the iStatis COVID-19 Antigen Home Test

bioLytical Laboratories Inc. announced today that it is launching a second test on its new platform, iStatis, after receiving Health Canada authorization for the iStatis COVID-19 Antigen Home Test for its immediate market entry into Canada

  • bioLytical has received Health Canada authorization to sell its iStatis COVID-19 Antigen Home Test across Canada for home use
  • The test is portable and can be performed in the comfort and privacy of home with a simple platform and easy-to-understand results
  • Test performance in clinical studies demonstrated industry-leading accuracy
  • bioLytical’s quality system is ISO 13485: MDSAP-certified

Richmond, B.C., April 01, 2022 – bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in-vitro medical diagnostics, announced today that it is launching its iStatis COVID-19 Antigen Home Test after receiving Health Canada Interim Order authorization, allowing its immediate entry into the Canadian market.

Building on its innovative INSTI® testing platform, the iStatis COVID-19 Antigen Home Test is on bioLytical’s newest platform, iStatis. With this additional lateral flow diagnostic technology, bioLytical can continue to reach more people, helping to provide peace of mind to Canadians looking to make informed health choices.

“We are excited to offer Canadians a COVID-19 test that they can take in the comfort and privacy of their own homes,” said Rob Mackie, Chief Executive Officer of bioLytical. “With this new test, we can help our home country get access to an accurate test when and where they need one. With the continuing scarcity of available home antigen tests, we saw an opportunity to support our country with a reliable home test from a local manufacturer they can trust.”

As the world learns to live with COVID-19, rapid testing is a vital tool to help identify infection and reduce exposure and transmission. Conducting regular testing provides an extra layer of defense. Home tests offer a convenient option to help Canadians make informed health decisions at home, at work, and in their communities.

To keep Canadians safe and secure, reliable testing access is necessary. Throughout the pandemic, healthcare systems were overwhelmed across the country. Along with the lack of PCR testing and scarcity of rapid antigen tests, it was difficult for Canadians to find and take COVID-19 tests when they needed one. With its high accuracy, portability, and ease of use, the iStatis COVID-19 Antigen Home Test will provide Canadians with a trusted home option.

bioLytical will manufacture the iStatis COVID-19 Antigen Tests in its ISO 13485: MDSAP-certified facility in Richmond, British Columbia, to sell and distribute across Canada. As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to ensure our iStatis COVID-19 Antigen Home Test kits are available to Canadians so they can know their status faster.