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Ten Canadian companies with rapid COVID tests awaiting Health Canada approval

People wait in their cars at the Credit Valley Hospital Drive-Thru coronavirus disease (COVID-19) testing facility in Mississauga, Ontario, Canada September 18, 2020. REUTERS/Carlos Osorio
People wait in their cars at the Credit Valley Hospital Drive-Thru coronavirus disease (COVID-19) testing facility in Mississauga, Ontario, Canada September 18, 2020. REUTERS/Carlos Osorio

At least ten Canadian companies have developed rapid COVID-19 tests and are awaiting approval by Health Canada. Epidemiologists say having rapid tests available to Canadians should help get the country past the pandemic sooner, but that the strategy for rolling them out is key.

Colin Furness, infection control epidemiologist and assistant professor at the University of Toronto, says putting pressure on Health Canada to speed test approvals isn’t helpful, but rethinking how these tests are developed and approved is a step in the right direction.

“As long as Health Canada uses these as diagnostic tests, that is, that produce a definitive diagnosis, they're going to dig in their heels about test sensitivity,” Furness told Yahoo Finance Canada. “If it's a screening tool, the sensitivity doesn't have to be as high, he added. “So, until Health Canada changes its conceptual framework, it's going to be slow.”

According to the Government of Canada website, there are ten Canadian companies with a rapid test under the review process from Health Canada. These tests are either lab-based tests (tests assessed by lab equipment) or point of care tests (COVID-19 tests supervised by healthcare professionals).
According to the Government of Canada website, there are ten Canadian companies with a rapid test under the review process from Health Canada. These tests are either lab-based tests (tests assessed by lab equipment) or point of care tests (COVID-19 tests supervised by healthcare professionals).

Health Canada approved the Panbio test from Abbott Rapid Diagnostics in Germany on Tuesday, being the first antigen rapid test to be approved by the regulator. Antigen tests assess markers outside of a virus that could lead to a positive diagnosis, separating it from the other three rapid tests approved which look for the virus’ genetic material only. Procurement Minister Anita Anand said Canada will purchase more than 20 million of these tests. This follows the announcement last week when the federal government stated it would buy 7.9 million ID Now rapid tests from U.S.-based Abbott Laboratories that would take 15 minutes to give a result. According to the Government of Canada website, there are at least ten Canadian companies with a lab-based test (in which the results are assessed by lab equipment) or point of care test (supervised by healthcare professionals).

One of these companies is the Halifax-based Sona Nanotech (SONA.CN), which developed the COVID-19 Lateral Flow Assay that is currently awaiting Health Canada approval. The point of care test works somewhat like a pregnancy test: place a nasal sample on a device strip that will show a colour-coded positive or negative result.

“What we really need is to be going out and auditing the population or a population to test the non-symptomatic so that we can identify breakouts before they occur,” said David Regan, the CEO of Sona Nanotech. “That is how tests like the Sona Nanotech rapid antigen test will have a transformative effect on this pandemic.”

The Dartmouth company is much smaller than the multi-billion dollar names in the U.S. biotech and nanotech space. Despite this, the company has been able to create the lateral assay test and is developing a saliva test that it hopes will be available to Canadian households after regulatory approval.

If the lateral flow assay test is approved, it could be used for screening purposes at public agencies and businesses, like border control services. “That's a great example of one area where there's enormous impact available from a little bit of effort in terms of, if every person entering the country could be administered a 15 minute test.”

Regan hopes the fact that the test is easy to read without additional equipment, technicians, or medical experts will better serve remote communities lacking full access to medical resources.

Some industries are moving to purchase tests for commercial use, like Air Canada which bought 25,000 rapid tests from Abbott to plan for safe travelling and resume travel. Positive results can take as little as five minutes while negative results can take 13 minutes to verify. The airline went through an experimental phase starting in early September and will now move ahead with the plan to use these tests for employee volunteers.

Furness argues that the rapid test isn’t the silver bullet to ensure widespread travel or a safe re-opening. He added that the individuals with high-risk occupations (like health care work, restaurant and bar service) should be prioritized instead of airlines and border security.

“This should not be an enabler for airlines - not until individuals have used it,” Furness said. “And that's to me absolutely vital.”

With files from the Canadian Press