bioLytical Laboratories Inc. Receives its CE Mark for the iStatis COVID-19 Antigen Home 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 its CE Mark for the iStatis COVID-19 Antigen Home Test for immediate entry to the European market
• The test is portable and can be performed at home with easy-to-understand results and no additional readers or machinery needed
• Test performance in clinical studies demonstrated an industry-leading 100% accuracy
• bioLytical’s quality system is ISO 13485:2016 MDSAP certified

bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in-vitro medical diagnostics, announced today that it is launching its new testing platform, iStatis, across Europe after receiving its CE Mark for the iStatis COVID-19 Antigen Home Test, allowing its immediate entry into the European market.

Building on its innovative INSTI® testing platform, bioLytical launched iStatis to continue creating reliable access to testing. With new lateral flow technology in its portfolio, bioLytical can reach more people with its COVID- 19 antigen home test that provides peace of mind with its industry-leading accuracy of 100%.

“We are excited to announce the addition of iStatis in Europe with our new COVID-19 rapid antigen home test,” said Rob Mackie, Chief Executive Officer of bioLytical. “With our new iStatis platform, we can expand our reach and increase access to testing across Europe. With the unpredictable nature of the pandemic, we are proud to offer Europeans a reliable and trusted test that they can take in the comfort and privacy of their own homes.”

Rapid testing is a vital tool that provides an additional way to identify infection to help reduce virus spread. Along with public health measures such as handwashing, masking, and social distancing, regular rapid testing provides an extra layer of defense against the transmission of the virus. With the pandemic evolving, testing will continue to play an integral role in the fight against COVID-19 by helping keep communities safe.The iStatis COVID-19 Antigen Home Test will help create certainty in infection identification, providing Europeans with access to a convenient test at home, reducing the burden on busy medical facilities. With its industry-leading accuracy of 100%, portability, and ease of use, iStatis provides reliable results, making informed health decisions easier and quicker.

bioLytical will manufacture the iStatis COVID-19 Antigen Home Tests in its ISO 13485:2016 MDSAP certified facility in Richmond, British Columbia. As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to ensure our iStatis COVID-19 Antigen Home Test kits are available across Europe.Referenceshttps://www.ecdc.europa.eu/en/covid-19/surveillance/testing-strategieshttps://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea- rst-update