TORONTO – DNA-based test kits developed by Ottawa-based Spartan Bioscience Inc. have been used in heart patient studies at the Mayo Clinic’s hospital network and by the New York City Department of Health to analyze bacteria in building water systems that can lead to Legionnaires’ disease. The portable kit now has received Health Canada approval for COVID-19 testing – this at a time when hospitals are under enormous pressure to meet increased testing demand.

“We get emails all the time from surgeons saying how all elective surgeries have been canceled – even for cancer patients – because they need to know if the patient they’re going to operate on is free of infection,” Spartan Bioscience founder and CEO Paul Lem told BioWorld. “Now we know our Spartan Cube works, and we’re shipping it out.”

Simple, in-your-fist testing

Lem calls the hand-held Spartan Cube – about the size of a coffee cup – “the world's smallest DNA analyzer.” Samples are collected with an oral or nasal swab and inserted into a single-use DNA test cartridge that extracts the DNA. Where traditional lab-based DNA testing can take days or weeks to obtain results, the Spartan Cube does it in less than an hour, said Lem.

“The way COVID-19 testing works now, you’ve got to collect the swab and then ship it off to a central lab that has main frame analyzers and highly trained technical personnel to get results,” said Lem. “We have the ability to generate that result on-site, with no need for a laboratory-trained person.”

Spartan Bioscience uses the same genetic sequencing already validated by the CDC based on 100% accuracy ratings across more than 2,000 clinical respiratory specimens. The Spartan Cube’s optical system detects increased fluorescence as algorithms automatically generate a test result that then is signaled by a light around the upper rim of the cube.

This makes it easy for nonmedical staff, such as building managers and security personnel, to test for COVID-19, said Lem.

It’s still not the fastest test, however. Illinois-based Abbott Laboratories Inc. recently came out with an isothermal nucleic acid amplification test that takes 15 minutes. However, isothermal technology “historically is less accurate than PCR,” said Lem. His goal is to speed up his test over the next several weeks, “to get a second version software upgrade of the Spartan Cube that can produce a test result in 30 minutes.”

This cupboard’s not bare

As worries mount in the U.S. over a limited supply of COVID-19 testing swabs and reagents, Spartan Bioscience’s local supply chain will keep it stocked up in nasal and mouth swabs indefinitely, said Lem. “Right now, there’s a global shortage of swabs. We’re not affected by this because we make our swabs in Ottawa.”

Aware of this, the federal government awarded Spartan Bioscience one of three contracts for the supply of rapid tests, portable ventilators and surgical masks. So far, Alberta is the only province to disclose its CA$9.5 million (US$6.5 million) contract for the purchase of 250 Spartan Cubes to be used to conduct 100,000 COVID-19 tests.

“We have a long track record with world-class technology,” said Lem. His hope is to extend that track record by ramping up production of the Spartan Cube to perform “several hundred thousand tests per week” by the summer. What’s it like getting out of bed every morning with the chance to have a direct, immediate impact on people’s medical wellbeing?

“I walk around my neighborhood, everything is shut down,” said Lem. “I read about the economic damage being done with millions of people losing their jobs and hundreds of thousands of people around the world dying. We feel honored to be doing something that really matters.”

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