After months of delays, Spartan Bioscience says Health Canada has given it the green light to start selling its rapid COVID-19 test.
The Ottawa firm’s Spartan Cube – a coffee cup-sized mini test lab that is expected to deliver results in less than an hour – initially received federal approval last April. The company calls it “the first truly mobile, rapid PCR test for COVID-19 for the Canadian market.”
But the device was recalled about a month later after Health Canada expressed concerns that the nasal swab used in the test wasn’t collecting sufficient amounts of the virus DNA from infected individuals to ensure accurate readings.
Spartan resubmitted the device for regulatory review in December after conducting further clinical trials in Canada and the United States.
“Slowing COVID-19 and re-opening the economy requires more testing, and Spartan is proud that our tests which have been researched, developed and manufactured right here in Canada are now available,” CEO Roger Eacock said in a statement.
Shipping to start 'immediately'
The company said it’s already resumed production of the Spartan Cube, adding it plans to begin shipping the device “immediately” to federal and provincial governments as well as commercial customers.
Spartan says the system "will be able to provide quality results to remote communities, industries and settings with limited lab access, helping relieve the burden on overwhelmed health-care facilities."
In an email to OBJ Saturday afternoon, a Health Canada spokesperson said the revamped test kit "meet's Health Canada's requirements for safety and effectiveness." She said the test reagents can be safely stored at room temperature and tests can now be done with any nasopharyngeal swab rather than Spartan's original proprietary swab.
Ontario’s Ministry of Health did not immediately respond to requests for comment.
In addition to providing health authorities with a groundbreaking new tool in the battle against COVID-19, the Spartan Cube could also give the company behind it a hefty financial boost.
Spartan said Saturday it expects 250 new jobs to be created as it ramps up production of the device. In an interview with OBJ in mid-November, Eacock said the test has attracted interest from customers around the world.
“Once we have Canada and the U.S., that’s going to open up a lot of the international market for us,” he said.
While Eacock – who took over as chief executive last fall after Spartan founder Paul Lem stepped down from the role earlier in 2020 – said he expected COVID-19 to be the firm’s main area of focus “for some time,” he said adapting the Cube for other uses would be a key to Spartan’s long-term success.
“The opportunities are quite significant,” he said. “It’s just a question of which one do we want to tackle first.”