TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north.

“I knew that gap wasn’t being filled and so right away we started taking measures to develop point-of-care tests and have them available,” Steven Newmaster, a University of Guelph genomics professor told BioWorld. “You can use the Bcube at airports and for employees, including those coming back from factories in the U.S. where there’s a risk of spreading the virus.”

Not one, but two biomarkers

Newmaster was called on by the CDC in December 2019 to perform genomic sequencing of biomarkers in infectious disease, work deemed vital when COVID-19 hit hard in February. Where other genome sequencing labs had come up with a single biomarker, Newmaster identified two markers he felt could form the genetic basis for a portable, COVID-19 testing kit.

“Instruments that only look at one marker may produce a false positive where you identify a cold virus and not the coronavirus,” said Newmaster. “It’s simply not as rigorous a test as one looking for two biomarkers.”

After validating the use of the Bcube to test for COVID-19, Newmaster contacted companies with a track record for producing these kinds of tools, asking ‘Do you want to develop a test to help society?’ Hyris, which produces Bcubes for agricultural purposes in Italy and Germany, jumped on immediately.

Two Ontario firms also heeded the call: Guelph-based specialty consulting engineers Rwdi Inc., and Mississauga genomic and biotech firm Purity-Iq Inc. Together they formed Songbird Life Science to commercialize and distribute the test kit. “When the next surge or pandemic-like virus emerges, we’re going to be able to quickly deploy that into the network of test instruments that are out there,” said Newmaster.

Someone tested for COVID-19 using the Bcube will submit their sample through either a nasal or oral pharyngeal swab. This will be prepped, slid into a cartridge and then slipped into the Bcube for a test that runs for ninety minutes. The machine then transports the data to a cloud-based system where it is made available to users.

The results also get the once over from AI-driven, mathematical algorithms, said Newmaster. Connected in “swarms,” several machines will use these to look at the results to see if any patterns associated with COVID-19 are developing, either in individual patients or across larger, patient populations.

Ottawa being tested, too

The last time we were presented with a cube-shaped kit for COVID-19 testing it was the Spartan Cube approved by Ottawa in April. Pulled back from the market after Guelph’s National Microbiology Laboratory questioned the efficacy of its swabs, the Spartan was restricted to research purposes only.

This was followed Sept. 29 by Ottawa’s announcement it was purchasing 7.9 million rapid point-of-care ID Now COVID-19 tests from Abbott Rapid Diagnostics ULC, a branch of Abbott Park, Ill.-based Abbott Laboratories Inc. – while simultaneously defending a regulatory process critics charge has slowed the country’s access to rapid testing devices, despite the current surge in COVID-19.

Worse perhaps, “the Abbott test is a quick screen, isothermal test,” said Newmaster. “Unlike our Bcube it’s not the double marker, PCR (polymerase chain reaction) test considered by the CDC to be the gold standard test for COVID-19 testing.” PCR has demonstrated a 95%+ accuracy rate in clinical trials.

That said, Songbird is hoping to have the Bcube also approved for isothermal tests, if for no other reason than their speed. Abbott’s isothermal test is still the rabbit at the racetrack in COVID-19 testing, identifying the virus in fifteen minutes flat. “Eventually you will be able to use our machine for both isothermal and PCR testing,” said Newmaster.

Previously approved for use in Europe for surface testing of COVID-19, the Bcube has absorbed “hundreds of thousands” of Canadian dollars to get it to the point where it can be used to test people for COVID, said Newmaster. When will the Bcube be ready for delivery?

“Songbird has hundreds of machines and thousands of kits that can be deployed tomorrow,” said Newmaster. “They’re trying to figure out the best way to do that. They’re in discussions with public health in each of the provinces and the federal government, including Health Canada.”

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