bioLytical Laboratories Inc. Receives CE Mark from iStatis COVID-19 Antigen Home Test, Canadian Business Journal

bioLytical Laboratories Inc. today announced the launch of the new platform iStatis, which received the CE mark for immediate market entry into Europe in the iStatis COVID-19 antigen home test.

  • From the INSTI® manufacturer, bioLytical has announced a new platform, iStatis. It was created to give everyone in the world access to trusted tests.
  • bioLytical has obtained the CE mark for the iStatis COVID-19 antigen home test for immediate entry into the European market.
  • The tests are portable, can be run at home, the results are straightforward, and no additional readers or machines are needed.
  • Test performance in clinical trials showed industry-leading 100% accuracy
  • bioLytical quality system is ISO13485: 2016 MDSAP certified

Richmond, British Columbia, March 21, 2022 (GLOBE NEWSWIRE) — BioLytical Laboratories Inc, a global leader in rapid in vitro medical diagnostics. (“BioLytical”) today announced that it will launch a new test platform, iStatis, across Europe. After obtaining the CE mark of iStatis COVID-19 Antigen Home Test, we have enabled immediate entry into the European market.

bioLytical is launching iStatis on the basis of the innovative INSTI® test platform, continuously creating reliable access to tests. By adopting new immunoflow technology in the portfolio, bioLytical can reach more people with the COVID-19 antigen home test, which provides peace of mind with industry-leading 100% accuracy.

Rob Mackie, CEO of bioLytical, said: “With the new iStatis platform, we can extend our reach and access to testing across Europe. Due to the unpredictable nature of the pandemic, we give Europeans the comfort and privacy of their homes. We are proud to provide reliable and reliable tests that we can accept. “

Rapid testing is an important tool that provides additional ways to identify infections that help reduce the spread of the virus. In addition to public health measures such as hand washing, masking, and social distance, regular and rapid inspections further enhance protection against viral infections. As the pandemic progresses, testing will continue to play an integral role in the fight against COVID-19 by helping to keep the community safe.

The iStatis COVID-19 Antigen Home Test helps ensure the identification of infections, gives Europeans access to convenient tests at home, and eases the burden on busy medical facilities. With industry-leading 100% accuracy, portability, and ease of use, iStatis delivers reliable results and makes informed health decisions easier and faster.

bioLytical manufactures iStatis COVID-19 AntigenHome Tests at an ISO 13485: 2016 MDSAP accredited facility in Richmond, British Columbia. bioLytical is a global leader in the diagnosis of ultrafast infectious diseases, working to make the iStatis COVID-19 Antigen Home Test Kit available throughout Europe.

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. 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 the INSTI® HIV-1 / HIV-2 antibody test, the INSTI® multiplex HIV Syphilis Ab test, the INSTI® HIV self-test, and the INSTI® Covid-19 antibody test. It is included. INSTI® 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. Receives CE Mark from iStatis COVID-19 Antigen Home Test, Canadian Business Journal

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