HOLD HOLD HOLD EMBARGOED UNTIL 5 A.M. NOV. 3 (OR WHENEVER BIOLYTICS GOES LIVES WITH A RELEASE.)
Federal regulators have approved the first HIV self-test in Canada in a long-awaited move that experts have called 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 telehealth 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.
This report by The Canadian Press was first published Nov. 3, 2020.
The Canadian Press