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

bioLytical Laboratories Inc. announced today that its INSTI® COVID-19 Antibody Test received authorization for immediate laboratory use in Canada.

RICHMOND, BRITISH COLUMBIA, CANADA, November 24, 2021 /EINPresswire.com/ -- • bioLytical’s INSTI^® COVID-19 Antibody Test is the world’s fastest at one minute
• bioLytical has received Health Canada approval for lab-based usage of the test
• Test performance in clinical studies demonstrated high accuracy of over 95%
• bioLytical's quality system is MDSAP and ISO 13485 certified

bioLytical Laboratories Inc.² (“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 Test¹ 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.

About bioLytical
bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI^® technology platform. bioLytical has won several local and industry awards, including B.C. Exporter of the Year in 2019. We have been named Lifesciences B.C.’s Growth Stage Med Tech Company of the Year and are featured on B.C.’s Fastest-Growing Companies for five years in a row, including the Globe and Mail’s Fastest Growing Companies list in 2020. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond, B.C., in 2020 to accommodate the extraordinary growth achieved through our team. Providing accurate results in one minute or less, the INSTI^® range includes the INSTI^® HIV-1/HIV-2 Antibody Test, INSTI^® Multiplex HIV Syphilis Ab Test, INSTI^® HIV Self Test, INSTI^® Covid-19 Antibody Test, and the INSTI^® HCV Antibody Test. bioLytical sells its products in Europe, North America, South America, Africa, and Asia.

By delivering accurate results in real-time, INSTI^® generates meaningful outcomes for medical professionals, patients, and public health organizations worldwide and is a key partner in tackling some of the world’s most severe healthcare challenges. Please visit www.insti.com and www.biolytical.com for more information.

References
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized/list.html
https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/symptoms/testing/diagnosing.html#a4
https://myhealth.alberta.ca/health/AfterCareInformation/pages/conditions.aspx?HwId=acl0817
http://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/

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¹ https://www.insti.com/covid19-antibody-test/
² https://biolytical.com/