Spartan Bioscience says Health Canada approves rapid COVID-19 test

Ottawa-based Spartan Bioscience has received Health Canada approval for its made-in-Canadarapid COVID-19 test, authorizing the sale of the device.

"The Spartan COVID-19 System offers the speed and ease of use of a rapid test, while using the technology of lab-based COVID-19 testing solutions,"a newsrelease from the company states.

The test offers hope because it is one of only a handful of approved quick-result tests that usesthe polymerase chain reaction (PCR) testing method widely consideredthe gold standard for accurate COVID-19 diagnostics at thepoint-of-care, without the need to send anythingto a lab.

The Spartan test isn't the first point-of-care PCR test to be approved in Canada, but it is the first to be made by a Canadian company with plans to sell solely to the Canadian market.

Health Canada originally provided regulatory approval for the company's device in April 2020 with the federal government ordering 40,000 tests monthly. At the time, the portable test was being called a"game changer" by healthofficials because it could deliver on-location results within 60 minutes.

• Health Canada pauses regulatory approval for COVID-19 rapid test

The federal agencyrestricted the device to research use in May, however,after finding problems with the test that made it unreliable. Approval was granted on Friday after the company conducted clinical trials based on a new device design, Health Canada spokespersonNatalie Mohamed told CBC News in an email.

"The Spartan Bioscience test is a point-of-care molecular test,"Mohamed wrote."This new device meets Health Canada's requirements for safety and effectiveness."

New swab, upgrades to chemistry kit

Dr. James Spiegelman, a co-founder of the company who also practises internal medicine at Humber River Regional Hospital in Toronto, said the problems stemmed fromtheefficacy of the swabs used to collect tissue samples, not the machine itself.

Spartan originally used a proprietary cheek swab that it developed for other DNA diagnostics, he said, but it became clear that the swab wasn't collecting enough genetic material to produce consistent, reliable results.

The company now uses standardnasopharyngeal swabs to collect tissue from the nose.

WATCH |Health Canada approves Canadian-made rapid COVID-19 testing system:

Health Canada approves Canadian-made rapid COVID-19 testing system

4 years ago

Duration 3:12

Canada's health authority approved Spartan Bioscience's rapid COVID-19 testing system.

"We found that that provides the best sample for increased sensitivity of the test," Spiegelmansaid.

Spiegelman said the company also made improvements to the sample processing kit so that it no longer needs to be shipped and stored at frozen temperaturesbut can be stored at room temperature.

With the Spartan test, a trained health-care professional swabs thenose of the person being tested, places the swab into aprocessing kit that generates a chain reaction and then puts that kit into the cube-shaped device, which takes about 50 minutes to analyze and produce results.

Spiegelman said the test could be used to provide quick and accurate COVID-19 diagnostics everywhere from hospitals andworkplaces to pharmacies andremote communities.

"I think [Spartan's rapid test] will really help alleviate and give us a tool in our toolbox to reduce the spread of COVID-19," he said.

Rapid tests already in use across Canada

Rapid diagnostic tests are already in use in many settings across Canada to test for COVID-19, including in homeless shelters, long-term care homes and remote communities. Prime Minister Justin Trudeau said lastTuesday that the federal government had distributed more than 14 million to the provinces and territories.

"Hopefullywe see these integrated into work environments, especially work environmentswhere we know they're at greater risk for outbreaks," said infectious disease specialist Dr. Isaac Bogoch, who is also a member of the Ontario COVID-19 vaccine task force.

"I think you could think about certainly integrating them into certain schools or certain school settings, rural, remote, underservicedlocations. There's a lot of places where rapid tests would be extremely helpful."

• Rapid COVID-19 test restricted by Health Canada will be fixed by summer, company's CEO says

Spartan Bioscience CEO Roger Eacocksaid the company currently has the manufacturing capacity to produce 60,000 tests per week, but itplans to ramp that up to 200,000 per week in the future.

Eacock said the company already has deals with the federal government and several provinces, as well as some airlines and resource companies, and that shipments are expected to begin in the coming week.

"Everything that we produce here today, we are going to be shipping internally within Canada to all of our Canadian accounts," hesaid. "So we're a dedicated supply chain to the Canadian market."