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, British Columbia, March 27, 2023 (GLOBE NEWSWIRE) -- 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. Furthermore, there is a growing concern about increasing congenital syphilis, with a 1271% increase in the same period.

With an estimated 62,790 persons living with HIV (PLWH) in Canada and with an estimated 1,520 new HIV infections annually, co-infection with syphilis and HIV is a growing concern. While both infections can affect anyone, having a STI such as syphilis increases the chance of acquiring HIV and in PLWH, increases the chances of passing on HIV. Additionally, syphilis sores or ulcers can allow HIV and other STIs to enter the body.

Rapid testing is instrumental in ending HIV and syphilis as public health threats. Regular and early access to testing allows medical professionals to offer early interventions by quickly connecting patients to care and support, reducing onward transmission, and increasing awareness of prevention methods.

If syphilis is diagnosed within a year of infection, it can usually be treated with a single injection of medication. HIV treatment has also progressed significantly since the virus was identified over 40 years ago, allowing persons living with HIV to lead long and healthy lives on treatment. Creating a test that can identify both infections with a single sample helps ensure that Canadians can connect to care quickly and equitably. The INSTI^® Multiplex HIV-1/2 Syphilis Antibody Test is an innovative and efficient approach to increasing access to early and regular testing for sexually transmitted and blood-borne infections (STBBIs) in Canada.

"With the rise of syphilis in Canada, including the concerning increase in congenital syphilis, there is an urgent need for a fast and reliable rapid diagnostic test," said Mackie. "With the development of a highly accurate and innovative one-minute test, INSTI^® allows Canadians to learn their status to two infections with only one drop of blood, helping more Canadians access testing, learn their status, and connect to care."

bioLytical will manufacture the INSTI^® Multiplex HIV-1/2 Syphilis Antibody Test in its MDSAP: ISO 13485-certified facility in British Columbia to sell and distribute across Canada. As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to ensure our test kits are available to Canadians so they can know their status.

bioLytical Laboratories Inc. is a privately-owned Canadian company focused on researching, developing, and commercializing rapid in-vitro medical diagnostics using its proprietary INSTI^® technology platform and its lateral flow line, iStatis. 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 featured on B.C.'s Fastest-Growing Companies for six years, 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. In 2022, bioLytical launched iStatis, its new lateral flow testing platform, to create additional access to testing worldwide.

By delivering accurate results in real-time, INSTI^® and iStatis generate 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.istatis.com and www.insti.com, and www.biolytical.com for more information.

References

CATIE: https://www.catie.ca/syphilis-0
PHAC: https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2022-48/issue-11-12-november-december-2022/infectious-congenital-syphilis-canada-2021.html
PHAC: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/estimates-hiv-incidence-prevalence-canada-meeting-90-90-90-targets-2020.html

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4adaf035-89ca-428d-a01d-9bf5c3f05e4b