Federal regulators have approved the first HIV self-test in Canada, a long-awaited move that experts have said is critical to reaching people who don’t know they have the virus.

Health Canada granted a medical device licence on Monday to a one-minute, finger-prick blood test manufactured by Richmond, B.C.-based bioLytical Laboratories.

Canada follows dozens of other countries in greenlighting the technology, which has been endorsed by the World Health Organization as a tool to reduce the number of people with undiagnosed HIV.

The principal investigator of a study that was submitted to regulators as part of their review says the approval of HIV self-testing could “open incredible doors” to increasing access to life-extending treatments and preventing the spread of infection in Canada.

Dr. Sean Rourke, a scientist with the Centre for Urban Health Solutions at St. Michael’s Hospital in Toronto, says he’s working with community organizations across the country to launch a tele-health program in January that will distribute 60,000 self-tests and connect people with care.

Rourke says the need for self-testing has become even more important as a recent survey of roughly 300 front-line providers suggests the COVID-19 crisis has cut access to clinical HIV testing services nearly in half.

Jason Mercredi, executive director of Prairie Harm Reduction in Saskatoon, welcomed the approval.

“The amount of [HIV] testing dropped,” Mercredi said. “We’re quite worried about HIV rates post-COVID.”

The more people that get engaged in getting HIV test results, the better, he said. 



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