bioLytical Laboratories Inc. Receives Health Canada Approval for Its One Minute Covid-19 Antibody Rapid Test

• bioLytical’s INSTI^® COVID-19 Antibody Test is the world’s fastest at one minute
• bioLytical has received Health Canada approval to sell across the country
• Test performance in clinical studies demonstrated high accuracy of over 99%
• bioLytical's quality system is MDSAP and ISO 13485 certified

Richmond, B.C., November 24th, 2021 - bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in-vitro medical diagnostics, announced it received Health Canada approval for the world’s fastest COVID-19 test for lab use across Canada. COVID-19 antibody testing plays an integral role in identifying and understanding community spread, helping with health investigations, and supporting epidemiologic and research studies to learn more about the virus. The INSTI^® platform uses innovative rapid flow-through technology to provide incredibly accurate results in real-time. It will allow laboratories to conduct testing, providing policymakers and medical professionals access to relevant and timely data to make effective decisions quickly.

bioLytical’s incredibly fast COVID-19 Antibody Test takes one minute to conduct and receive results. It will help governments and medical professionals offer an effective tool to tackle the spread of the COVID-19 virus. In an ongoing pandemic, identifying and monitoring community spread is critical to helping communities across Canada re-open safely. Due to our market-leading test speed, laboratories have the advantage of running more tests in less time using the INSTI^® COVID-19 Antibody Test. With real-time results and more than a 95% accuracy rate, the test is a cost-effective solution to mass-testing and serosurveillance.

Leveraging bioLytical’s proven INSTI^® technology, the INSTI^® COVID-19 Antibody Test is designed to test the entire spike protein, providing confidence that the test results are accurate and thorough.

“With our proven INSTI^® platform, bioLytical is confident that our test can play an essential role in understanding the prevalence of COVID-19 in Canada and can help track the country’s immunity status,” said Robert Mackie, Chief Executive Officer of bioLytical. “We are happy to provide our home country with a tool that helps identify community spread and offer policymakers and medical professionals additional support in determining a safe framework for tracking the spread of the virus and in re-opening society.”

As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to bring our INSTI^® COVID-19 Antibody Test kits to as many labs as possible. bioLytical will manufacture the INSTI^® COVID-19 Antibody Tests in its facility in Richmond, British Columbia, to sell and distribute across Canada. In addition, bioLytical is working with Health Canada to launch a point-of-care test that utilizes a fingerstick method to allow healthcare workers to test patients, travellers, and consumers quickly and flexibly in different test environments. Referenceshttps://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/symptoms/testing/diagnosing.html#a4https://myhealth.alberta.ca/health/AfterCareInformation/pages/conditions.aspx?HwId=acl0817http://www.bccdc.ca/health-professionals/clinical-resources/covid-19-care/covid-19-testing/antibody-testing-(serology)https://discoverysedge.mayo.edu/2020/04/03/the-importance-of-antibody-testing-in-addressing-covid-19/