Ottawa-based company Spartan Bioscience has received Health Canada approval for its made-in-Canada rapid COVID-19 test, authorizing the sale of the device.
“Spartan’s test is the first truly mobile, rapid PCR test for COVID-19 for the Canadian market,” a news release from the company states. “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.”
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 health officials because it could deliver on-location results within 60 minutes.
The federal agency restricted 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 spokesperson Natalie 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.”
WATCH | Health Canada approves Canadian-made rapid COVID-19 testing system:
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 from the efficacy 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 standard nasopharyngeal swabs to collect tissue from the nose.
“We found that that provides the best sample for increased sensitivity of the test,” Spiegelman said.
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 temperatures but can be stored at room temperature.
With the Spartan test, a trained health-care professional swabs the nose of the person being tested, places the swab into a processing 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 and workplaces to pharmacies and remote 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 on Tuesday that the federal government had distributed more than 14 million to the provinces and territories.
“Hopefully we see these integrated into work environments, especially work environments where 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, underserviced locations. There’s a lot of places where rapid tests would be extremely helpful.”
Spartan Bioscience CEO Roger Eacock said the company currently has the manufacturing capacity to produce 60,000 of the tests per week, but the company plans 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.
Health Canada has authorized Novavax’s updated COVID-19 vaccine that protects against currently circulating variants of the virus.
The protein-based vaccine, called Nuvaxovid, has been reformulated to target the JN.1 subvariant of Omicron.
It will replace the previous version of the vaccine, which targeted the XBB.1.5 subvariant of Omicron.
Health Canada recently asked provinces and territories to get rid of their older COVID-19 vaccines to ensure the most current vaccine will be used during this fall’s respiratory virus season.
Earlier this week, Health Canada approved Moderna’s updated mRNA COVID vaccine.
It is still reviewing Pfizer’s updated mRNA vaccine, with a decision expected soon.
This report by The Canadian Press was first published Sept. 19, 2024.
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
Note to readers: This is a corrected story. A previous version erroneously described the Novavax vaccine as an mRNA shot.
HALIFAX – The federal Fisheries Department says an endangered North Atlantic right whale has become entangled in gear in the Gulf of St. Lawrence.
The department says the whale was sighted Wednesday by a Transport Canada aerial surveillance team northeast of the Gaspé Peninsula, off Anticosti Island.
Officials say it’s not known what type of gear has entangled the whale or where the gear came from.
Based on observation, experts at the New England Aquarium have confirmed the whale is a female known as Chiminea.
The department says it is continuing to monitor the area and if the whale is located and conditions allow, efforts will be made to disentangle the animal.
Last October, the North Atlantic Right Whale Consortium estimated there were 356 North Atlantic right whales left on the planet.
This report by The Canadian Press was first published Sept. 19, 2024.
VANCOUVER – Canadian pop icon Nelly Furtado has been named one of three headliners for the opening ceremony of the upcoming Invictus Games.
Furtado, from Victoria, will share the stage with alt-pop star Roxane Bruneau of Delson, Que., and American singer-songwriter Noah Kahan.
They’ll be part of the show that opens the multi-sport event in Vancouver and Whistler, B.C., in February.
The Invictus Games sees wounded, injured, and sick military service members and Veterans compete in 11 disciplines.
The Vancouver Whistler 2025 Games will be the first of seven editions to feature winter adaptive sports, including alpine skiing, Nordic skiing, skeleton and wheelchair curling.
British Columbia’s Lower Mainland will host the Invictus Games from Feb. 8-16.
This report by The Canadian Press was first published Sept. 19, 2024.
