Health Canada pressed to ramp up rapid testing
Infectious disease experts say approval urgently needed as cases rise across the country
Health Canada needs a comprehensive strategy focused on evaluating and ramping up rapid testing as cases rise across the country, infectious disease experts say.
In comparison to the United States’ Food and Drug Administration (FDA)’s emergency approval process, Health Canada has been slower to give approval to COVID-19 tests.
The agency currently has almost a hundred COVID-19 tests under evaluation, from all over the globe. These range from rapid tests to be administered by a health professional, labbased tests that require samples to be evaluated elsewhere, and antibody tests.
Ten Canadian companies are on Health Canada’s list, including Biocan Diagnostics Inc. of Coquitlam, B.C. Its antibody test already has emergency FDA approval.
Diagnostics Biochem Canada Inc., of London, Ont., has four different tests awaiting approval. The company is on the National Research Council Canada’s website as a spotlighted company.
Andrew Morris, an infectious disease specialist at Sinai Health and University Health Network, said the FDA has been approving COVID-19 tests “more aggressively” than Health Canada. Of course, rapid approval has downsides: The FDA has been “burnt” by at least one product, he said.
Nonetheless, “I think there’s no question that we could improve how we’re going about getting test approval,” he said.
Health Canada should be taking a strategic approach at evaluating tests, said Morris, putting more focus on rapid tests and less focus on serologic tests, or antibody tests.
“Health Canada is inundated with serologic technologies, but serologic technologies don’t tremendously help us,” he said, because they don’t test for current cases of COVID-19.
“What we really need to do is figure out ways to increase our overall throughput and capacity (of COVID-19 testing),” he said.
Morris said while Health Canada is and should be evaluating tests for their reliability, it could approve less reliable rapid tests for use in certain settings. For example, at schools; if a child is tested daily, the margin of error for the test shrinks.
There are a lot of lab-based tests under evaluation in Canada, said Morris, adding he hopes Health Canada will focus on evaluating more home-based and point-of-care rapid tests.
“They may be doing that. But it’s certainly not transparent,” he said.
Biocan’s vice-president of sales Bhavjit
Jauhar said in an email that the company has received zero communication from Health Canada despite having “excellent evaluation results.”
Jauhar said Health Canada should be taking into consideration tests already approved by the FDA, at least as a shortterm, emergency approval. He believes Canada is not placing enough importance on antibody tests.
Health Canada spokesperson Geoffroy Legault-Thivierge said in an email, that the agency has “taken numerous steps to expedite the availability of medical devices in support of COVID-19 response efforts.”
In particular, two interim orders signed in March provided expedited authorization pathways for medical devices and facilitated access to alternate supplies of health products, he said.
He added Health Canada is expediting the evaluation and issuance of Medical Device Establishment Licences (MDEL) for companies applying to manufacture Class I medical devices, or import or distribute Class I-IV medical devices in support of COVID-19 response efforts.
Canada recently approved its first rapid test, called ID Now, by U.S.-based Abbott.
A similar test, also by Abbott, was approved by the FDA in August.
Zain Chagla, an infectious disease specialist with McMaster University, generally favours Health Canada’s more careful approach over the FDA’s.
However, he agreed that the agency should be focusing on rapid testing, especially platform-less tests that can be administered easily outside a health care setting.
The Abbott ID Now is not platform-less, he said, but Abbott has other tests that meet this criteria.
This kind of rapid test could be used to screen children with runny noses before they go to school, for example — as long as the public is aware of the limitations, he said.
“There certainly is a need to prioritize something like that coming to the market,” he said.
Chagla agreed that it’s time for a widespread strategy of implementation for these tests, so that when they are approved, they can be rolled out quickly.
David Juncker, a professor of biomedical engineering at McGill University, said rapid tests will be key to Canada’s pre-vaccine strategy, and the more rapid testing is available, the more Canadians will be able to continue doing things like sending their children to school and eating in restaurants.
Juncker thinks it’s time Canada developed a national strategy for the ramping-up of rapid testing, one that goes beyond Health Canada and includes industry, scientists and more.
“The ability to test frequently, I think, is going to be very critical,” he said.
Overall, Canada hasn’t been proactive or strategic enough, Juncker said. The next several months of the pandemic will require strategy, planning and risk-taking.
The technology to make these tests is already available, he added. It’s just a matter of putting resources into mass production.
“The technology for this test is very well established from the ’80s, it’s patent-free, so we could just commission someone,” he said.