bioLytical Laboratories Inc. Receives Health Canada Authorization for its INSTI® Multiplex HIV-1/2 Syphilis Antibody Test

• bioLytical has received Health Canada authorization to sell its INSTI^® Multiplex HIV-1/2 Syphilis Antibody Test across Canada for professional use in point-of-care settings
• By providing results for two infections with only one sample, the test helps reduce test anxiety for patients by allowing healthcare professionals to test more people in less time
• The test is portable and can be performed in a multitude of settings with easy-to-understand results
• As part of the Health Canada review and authorization, the submission included clinical data from the two-year PoSH Study led by researchers at the University of Alberta and St. Michael's Hospital, a site of Unity Health Toronto
• Test performance in clinical studies demonstrated high accuracy, with industry-leading sensitivity and specificity
• bioLytical's quality system is MDSAP: ISO 13485 certified

Richmond, B.C., March 27, 2023 - bioLytical Laboratories Inc. ("bioLytical"), a global leader in rapid in-vitro medical diagnostics, announced today that it has received Health Canada authorization for its INSTI® Multiplex HIV-1/2 Syphilis Antibody Test, allowing its immediate entry into the Canadian market. Furthermore, bioLytical is working on a self-test version to ensure Canadians of all demographics can access regular and early testing for both infections, where and when it works best for them.

"I am proud to lead a team of hardworking and innovative individuals who consistently push the boundaries of what is possible," says Rob Mackie, CEO of bioLytical. "Our continued dedication to excellence allowed us to achieve this remarkable milestone that will help Canadians across all demographics access early testing in various settings."

As a well-known leader in global HIV testing with its innovative INSTI® HIV-1/2 Antibody Test, authorized by Health Canada for both professional and self-testing use, bioLytical has leveraged its proprietary INSTI® technology to develop the INSTI® Multiplex HIV-1/2 Syphilis Antibody Test, first approved and in use across Europe and Africa since 2016.

The test is designed to detect both HIV-1/2 and syphilis antibodies with one sample using a simple fingerprick method to deliver accurate results in one minute or less. Mobile and simple to use, INSTI® allows healthcare professionals to test in various environments, providing flexible options for persons that face barriers to accessing healthcare.

As part of Health Canada's review and subsequent authorization, the two-year Point of Care Tests for Syphilis and HIV (PoSH) Study, completed between August 2020 and February 2022, was included in the submission process. The Study, led by researchers at the University of Alberta and St. Michael’s hospital, a site of Unity Health Toronto, showcased the importance of regular and frequent testing to help connect patients to care. Due to the real-time results that the innovative INSTI® platform provides, those who tested positive for HIV were either linked or relinked to care, and of those that tested positive for active syphilis, the majority (87.4%) were treated immediately following point-of-care test results, and the remaining participants were treated within a median of four days.

Syphilis is a serious health issue that can lead to long-term health consequences if left untreated. Canada is currently experiencing unprecedented syphilis infection rates, with a 166% nationwide increase from 2017-2021. Rates have increased across all demographics, with new infections increasing by 20% between 2020 and 2021 despite decreased access to STBBI services during the pandemic.