Health Canada mum on future availability of in-home oral HIV test
Kenyon Wallace
Toronto Star
July 04, 2012 - Health Canada and the company responsible for an oral HIV test approved by the U.S. Food and
Drug Administration for home use are staying mum on whether the product will soon be available in Canada.
A spokesperson for Pennsylvania-based OraSure Technologies, maker of the OraQuick In-Home HIV Test, told the Star Wednesday
the company is looking outside the United States to market the product, "but no definitive plans have been finalized."
There is no oral HIV test available for sale in Canada.
Companies wishing to market medical devices in this country must submit a licence application to Health Canada, which reviews
the product to ensure it meets the requirements of medical device regulations.
Health Canada spokesperson Olivia Caron would not confirm whether the agency had received any applications to market the test
in this country.
"Information related to licence applications to Health Canada is considered confidential. As a result, we are unable to
comment on any licence application that has not received approval," she said.
The new in-home test, which will be available in 30,000 retail locations across the U.S. by October, uses a swab to collect
saliva and other material from the mouth and can detect HIV antibodies in 20 minutes. It is the first over-the-counter rapid diagnostic
test for an infectious disease approved by the FDA.
Dr. Mark Wainberg, head of HIV/AIDS research at Lady Davis Institute in Montreal, said he hopes the test will soon be made
available in Canada.
"If people at risk know they are positive, chances are they will practice safer sex than they would if they didn't know and
this will protect others and diminish transmissions," he said, adding that a positive result would also hopefully encourage those
infected to seek treatment.
"What's the downside? Well, if the test is offered without counselling, someone who is prone to be despondent could
potentially harm themselves, as an example. But, this argument first surfaced when we didn't have good drugs. Now that we do,
there is hopefully no reason to be despondent in the first place."
According to the Public Health Agency of Canada, there are an estimated 65,000 people living with HIV in Canada, of whom about
16,900 - or 26 per cent - are unaware of their infection.
The availability of an in-home oral test in Canada would also help eliminate the anxiety associated with waiting for two weeks for the results of a standard blood test, said Sean Hosein, a spokesperson for the Canadian AIDS Treatment Information Exchange. But he stressed the in-home test result is provisional and should be followed-up with another test to confirm it.
"It's a step to get people into the health-care system," Hosein said. ". . . Anything that encourages people to get tested is
a great idea."
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Source: http://www.thestar.com/news/canada/politics/article/1221577--health-canada-
"Reproduced with permission - Torstar Syndication Services"
Toronto Star
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