Canada’s First HIV Self Test Receives Licence

November 3, 2020

Made-In-Canada INSTI® HIV Self Test Provides Results in 1 Minute and is More Than 99% Accurate

For the first time, Canadians will have access to at-home HIV self test kits. bioLytical Laboratories, a world leader in rapid infectious disease tests, announced today that it has received Health Canada Licence to produce and sell its highly accurate, 1-minute INSTI® HIV Self Tests in Canada.

Likened to a home pregnancy test, the INSTI® HIV Self Test allows individuals to screen and monitor for HIV in the comfort of their own home, using easy-to-understand, three-step instructions. Testers collect one drop of blood using a simple fingerstick method and receive results that are more than 99 per cent accurate in only 1 minute. The INSTI® HIV Self Test is part of bioLytical’s world-leading line of 1-minute tests for infectious diseases including HIV, Hepatitis C, Syphilis and now, COVID-19.

Contrary to the popular belief, HIV infections are still on the rise in Canada. It is estimated that 14 per cent of people living with HIV nationwide do not know their status. The introduction of HIV self-testing provides new opportunities to reach the undiagnosed, which can lead to better health outcomes and fewer new HIV transmissions.

“Ending the HIV epidemic starts with testing. By providing innovative options like our 1-minute INSTI® HIV Self Test, we can help people who are unaware of their HIV status to learn the facts and make informed health decisions much faster,” says bioLytical’s Chief Executive Officer, Robert Mackie. “In addition, bioLytical has received approval in Europe and is currently in FDA trials for our COVID-19 Antibody test, which uses the same 1-minute INSTI® self-testing technology.”

The approval of the INSTI® HIV Self Test comes a year after the launch of a ground-breaking field study at three sites across Canada which proved that individuals without medical training could perform the 1-minute self-test and interpret their results accurately. The study was jointly funded by The CIHR Centre for REACH 3.0 and the Canadian Foundation for AIDS Research (CANFAR) and was led by Dr. Sean B. Rourke at the MAP Centre for Urban Health Solutions at St. Michael’s Hospital.

The study provided data to support bioLytical’s application for Health Canada Licence, reporting that users found INSTI® HIV Self Test to be accurate and easy to use. In fact, over 95% of the study participants indicated they would use INSTI again and would recommend it to family, friends, and sexual partners.

Dr. Rourke said, “We are excited to be bringing HIV self-testing to Canada to reach the undiagnosed – it’s long overdue, and without this option, we will not be able to end the HIV epidemic in Canada. Now approved, REACH is working closely with front-line community-based HIV organizations and other health agencies to develop, implement and scale-up a national (online) telehealth platform with peer navigators to support access to, and support with, HIV self-testing as well as linkage to care.”

The test will be available for purchase this week from INSTI.com. For more information and to sign up for updates, please visit insti.com/self-test-canada.

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November 3, 2020

Canada’s First HIV Self Test Receives Licence

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