City company's COVID test kit gets Health Canada OK
When Dr. Jamie Spiegelman learned Friday that Health Canada had finally approved the Spartan Bioscience COVID -19 test kit for emergency use, his overwhelming emotion was one of relief.
It has been nearly nine months since Ottawa-based Spartan, the lone Canadian entrant in this specialized niche, withdrew its product after substandard test results. That disappointment was followed by months of intensive re-engineering and clinical trials in Canada and the U.S.
Now, finally, Spartan is back on track.
“This is going to be a game-changer in making diagnoses and helping to open the economy,” Spiegelman said. The test kit, dubbed the Spartan Cube, is a portable lab-in-a-box that tests for the SARS-CoV-2 virus that causes COVID-19. The Cube produces results in about one hour, compared to days for tests done through laboratories.
In anticipation of a favourable Health Canada ruling, Spartan has been bolstering its internal R&D workforce and manufacturing operations. Sanmina's Toronto plant is handling high-volume production, while L-D Tool & Die of Ottawa is doing prototypes, among other things. The Cube, the container, is built by Taiwan-based Wistron, also an investor in Spartan.
Shipments to the federal government are expected to begin as early as Monday, with provincial deliveries to follow. Spartan is already producing 60,000 test kits per week and expects by the end of February to pump out 200,000 per week. That would make a significant contribution to Canada's COVID-19 testing effort, which recently topped 650,000 weekly.
Assuming no further hiccups, Spartan looks to be on track to top $200 million in revenues this year based on government orders alone. Its technology is also well-suited for use by airlines and private businesses anticipating reopening. “We are still ramping up R&D because this is a huge and significant opportunity,” said Roger Eacock, Spartan's CEO since October. “We have buyers already lined up,” he added in reference to private-sector customers.
He stressed that Spartan would fulfil its commitments to governments as a first priority, but added he believed there was enough flexibility in production to serve private-sector firms at the same time.
Last spring, Alberta, Ontario, Quebec and the federal government ordered nearly two million test cartridges and the Cube devices that process them — approaching $200 million worth of potential business with more to follow, all of it contingent on the performance of the initial samples and Health Canada approval. With this in hand, Spartan can start making good on those initial purchase orders.
In retrospect, Spartan pushed its technology faster than it should have, no doubt influenced by the intensity of the first wave of COVID-19 and the urgent need for portable tests. Quite simply, Spartan's early method of collecting nasal samples didn't pick up sufficient quantities of the virus for accurate tests.
Spiegelman, who has more than a passing interest in Spartan's breakthrough, has some thoughts about that. He is a co-founder with Paul and John Lem and a board member. Spiegelman is also a physician at Humber River Regional Hospital in the epicentre of Toronto's COVID-19 outbreak. That makes him desperate to get COVID-19 tests done quickly and accurately.
The physician said he was not consulted by the firm on the design of the initial test kit submitted for Health Canada's inspection. He knows the viral load is heaviest deep in the back of the throat, thus requiring lengthy nasal swabs for good samples, but Spartan early on submitted its shorter, proprietary swab as part of the package.
“It didn't get big enough samples of the virus,” Spiegelman said. Not only that, he added, the test kit's chemicals had to be kept frozen while in transit, thus introducing complications to the supply chain and making deliveries to remote regions more difficult.
The good news was that Spartan's DNA-analyzing technology was solid, so the company opted to remake the test kits to rely on longer, standard-issue swabs and a storage solution that worked at room temperature. It was a significant R&D effort.
The result is a product that does not require a lot of training to use.
“I taught my five-year-old daughter to use this in five minutes,” Spiegelman said.
While portable DNA analyzers are generally less accurate than lab-based technology, the efficacy of the Cube now seems well suited for the fight against COVID-19, which demands rapid results. Spiegelman said the clinical trials suggested a positive COVID-19 test result on the Cube is nearly certain to be accurate, while a negative result is 80 per cent to 90 per cent likely to be accurate.
If these kinds of results play out in the months to come, Spartan can afford to contemplate a future beyond COVID-19. Because the Cube analyzes DNA, it could be adapted to test for other viruses.