bioLytical Laboratories Inc. has been approved by Health Canada’s iStatis COVID-19 Antigen Home Test, Canadian Business Journal.

bioLytical Laboratories Inc. today announced that it will begin a second test on its new platform, iStatis, after being approved by Health Canada for the iStatis COVID-19 Antigen Home Test for immediate market entry into Canada. ..

  • bioLytical has been licensed by Health Canada to sell the iStatis COVID-19 AntigenHomeTest for home use throughout Canada.
  • The tests are portable and can be run in the comfort and privacy of your home with a simple platform and easy-to-understand results.
  • Test performance in clinical research showed industry-leading accuracy
  • bioLytical quality system is ISO13485: MDSAP certified

Richmond, British Columbia, April 1, 2022 (GLOBE NEWSWIRE) — BioLytical Laboratories Inc, a global leader in rapid in-vitro medical diagnostics. (“BioLytical”) announced today that it will begin the iStatis COVID-19 antigen home test. Approved by Health Canada’s provisional order, it enables immediate entry into the Canadian market.

Built on the innovative INSTI® test platform, the iStatis COVID-19 Antigen Home Test is on iStatis, the latest bioLytical platform. With this additional lateral flow diagnostic technology, bioLytical can continue to reach more people and help provide peace of mind to Canadians seeking informed health choices.

Rob Mackie, CEO of bioLytical, said: “This new test gives our home country access to accurate tests when and where they need them. Reliable by a trusted local manufacturer due to the continued shortage of home antigen tests available. I had the opportunity to support Japan through home inspections. “

As the world learns to live with COVID-19, rapid diagnostics are an important tool to help identify infections and reduce exposure and infections. Performing regular tests provides an additional layer of defense. Home exams provide convenient options for Canadians to help Canadians make informed health decisions at home, at work, and in the community.

To keep Canadians safe, you need reliable test access. During the pandemic, the medical system was overwhelmed nationwide. In addition to the lack of PCR testing and the lack of rapid antigen testing, it was difficult for Canadians to find and receive the COVID-19 test when needed. The iStatis COVID-19 Antigen Home Test provides Canadians with a reliable home option due to its high accuracy, portability and ease of use.

bioLytical manufactures the iStatis COVID-19 antigen test at an ISO 13485: MDSAP accredited facility in Richmond, British Columbia, and sells and distributes it throughout Canada. As a world leader in ultrafast infectious disease diagnosis, bioLytical is committed to ensuring that the iStatis COVID-19 Antigen Home Test Kit is available to help Canadians know their condition faster.

Media contacts
Communication with bioLytical
+ 1-778-238-9340

bioLytical Laboratories Inc. is a Canadian privately owned company focused on the research, development and commercialization of rapid in vitro medical diagnostics using its unique INSTI® technology platform and its lateral flow line, iStatis. am. bioLytical has won several regional and industry awards, including the 2019 BC Exporter of the Year. It has been named to Lifesciences BC’s Growth Stage Med Tech Company of the Year and has been listed as one of BC’s fastest growing companies for the fifth consecutive year. Globe and Mail’s fast-growing companies are listed in 2020. bioLytical moved to a very large, state-of-the-art facility in Richmond, British Columbia in 2020 to meet the tremendous growth achieved through the team. The INSTI® series, which provides accurate results within 1 minute, includes INSTI® HIV-1 / HIV-2 antibody tests, INSTI® multiplex HIV syphilis antibody tests, INSTI® HIV self-tests, and INSTI® Covid-19 antibody tests. , And INTI® HCV antibody test. bioLytical sells products in Europe, North America, South America, Africa, and Asia. In 2022, bioLytical launched iStatis. This is a new immunoflow test platform for creating additional access to tests around the world.

By providing accurate results in real time, INTI® and iStatis deliver meaningful results to healthcare professionals, patients, and public health organizations around the world, addressing some of the world’s most serious healthcare challenges. Is an important partner in. For more information, please visit, and


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bioLytical Laboratories Inc. has been approved by Health Canada’s iStatis COVID-19 Antigen Home Test, Canadian Business Journal.

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