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BioLytical Laboratories Inc. Receives Health Canada Authorization for its iStatis COVID-19 Antigen

Updated: Mar 4, 2022

bioLytical Laboratories Inc. announced today that it is launching a new platform, iStatis, and has received Health Canada authorization for immediate market entry into Canada for its first product, the iStatis COVID-19 Antigen Test.

· From the makers of INSTI®, bioLytical launches a new platform, iStatis, created to ensure every person in the world has access to reliable testing

· bioLytical has received Health Canada authorization to sell its iStatis COVID-19 Antigen Test across Canada for professional use in point-of-care settings

· The test is portable and can be performed in a multitude of settings with easy-to-understand results

· Test performance in clinical studies demonstrated high accuracy, with industry-leading sensitivity and specificity

· bioLytical's quality system is MDSAP and ISO 13485 certified

Richmond, B.C., March 7, 2021 - bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in-vitro medical diagnostics, announced today that it is launching a new testing platform, iStatis, which has received Health Canada authorization for its iStatis COVID-19 Antigen Test, allowing its immediate entry into the Canadian market.

Building on its innovative INSTI® testing platform, bioLytical launched iStatis to continue creating reliable access to testing. With additional lateral flow technology in its portfolio, bioLytical can reach more people with its COVID-19 antigen test that provides peace of mind with its industry-leading accuracy.

“We are excited to announce the addition of iStatis with our new COVID-19 rapid antigen test,” said Rob Mackie, Chief Executive Officer of bioLytical. “With this new platform, we are able to expand our reach, creating more equitable access to testing. With the scarcity of available antigen tests, we saw an opportunity to ensure that Canadians have a reliable test they can trust.”

Rapid testing is an instrumental tool in the fight against the pandemic, providing an additional way to identify infection and reduce the spread of the virus. Conducting regular rapid testing provides an extra layer of defense against the spread of the virus along with other public health measures such as physical distancing, masking, and handwashing. With new variants expected to continue, testing will continue to play an integral role in reducing the spread of the virus and keeping Canadians safe at home, at work, and in society.

With COVID-19 expected to remain, Canada needs secure access to reliable and trusted testing. With overwhelmed healthcare systems across the country, lack of access to PCR testing, and a low supply of rapid tests, the iStatis COVID-19 Antigen Test will help play a role in identifying infection and helping Canadians make safe and informed decisions regarding their health. With its high accuracy, portability, and ease of use, the iStatis COVID Antigen Test allows healthcare professionals the ability to test in multiple environments, reducing the burden on busy hospitals and medical facilities.

bioLytical will manufacture the iStatis COVID-19 Antigen Tests in its MDSAP and ISO 13485-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 Test kits are available to Canadians so they can know their status.


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