Health Canada has halted orders of COVID-19 testing devices from Ottawa-based pharmaceutical company Spartan Bioscience.
While testing The Spartan Cube, the National Microbiology Laboratory, found that the carriage of the device worked well but the swab used to collect the sample appeared to need some retooling.
Tests in the federal lab found the swab that accompanies the kit isn’t collecting enough material to properly test for the virus. The swab, which has been used in other tests on the inside of the cheek, was repurposed for the COVID-19 tests to be used in the nose and back of the throat. However, the National Microbiology Laboratory found it wasn’t as effective when used in this way.
The company now intends to modify the tip of the swab so it successfully collects more material from the patient’s nose and back of the throat. They will do this by making the surface more textured.
Spartan’s CEO Paul Lem told CBC that the company is still scaling up production and that creating a more effective swab is a minor technical issue to fix. He suspects it will take a few weeks to make changes to the swab and produce a large quantity of them to bring to a clinical study to assure they work.
Lem suspects his company will be shipping out hundreds of thousands of tests per week by the summer. The company voluntarily recalled 5500 tests that have already been shipped out.
Spartan Bioscience was tapped by several governments to produce the rapid tests.
The test, which is about the size of a portable speaker, can take either nose or throat swabs and can be administered by non-laboratory workers. By taking out that step, it allows for faster results from testing at places like doctors’ offices, pharmacies, airports, and border crossings.
“There is an urgent unmet need for rapid COVID-19 testing, and as a proudly Canadian company, we are excited that our technology will be an important part of fighting the COVID-19 pandemic in Canada,” Lem said in a press release.
Spartan Bioscience has primarily developed products that range from contaminated water tests to the world’s smallest DNA test. Some of its customers include the American Centers for Disease Control (CDC), the New York State Department of Health and the Mayo Clinic.
So far, the province of Ontario has ordered 900,000 of the company’s COVID-19 tests, while the province of Alberta will pay $10-million for 250 portable DNA analyzers and 100,000 tests.
“We have been spending millions and millions of dollars in the last week and a half to ramp up our supply chain,” Lem told Yahoo Canada.
They are aiming to have manufacture millions of tests in the next 12 months.
Lem described the current energy at his company as “absolutely insane” since “we know that every day matters.”
“We’re looking to ship out product as quick as humanly possible,” he says.
For the past 14 years, Spartan Bioscience has been focused on developing a portable DNA analyzer, which turned out to be well suited for something like the COVID-19 outbreak.
“Right now with testing, the central labs are being overwhelmed because people have to collect a swab, ship it off to a lab, then wait days to get the results back,” says Lem.
In contrast, the company’s analyzer a square cube that can be held in one hand. Once a swab has been collected, it’s put in a test cartridge and then a box, and results are available within half an hour.
Lem explains that DNA testing works like a blood glucose metre. The device has a test strip, which tests for whatever specific thing you’re looking for. Once a sample is taken from the mouth or back of the nose, it’s placed in the single-use cartridge, which is then inserted into a box. Thirty minutes later, it displays results.
The company is in need of financing and purchase orders, and is working with the government to get that capital in place. They’re also looking to work with private investors to fund the company to scale.
Prime Minister Justin Trudeau announced in March that the government is working with Spartan Bioscience and two other companies to ramp up supplies for essential medical services, including tests for COVID-19.
“We anticipate (the tests) will be available through the government, they’ll give us purchase orders and then help us disseminate our tests across the country,” Lem said. “We want to do our best in the fight against COVID-19.”
This story was updated on May 5, 2020.