Health Canada approves new fast, portable COVID-19 test

Ottawa’s Spartan Bioscience today announced it has received Health Canada approval for its rapid, accurate and portable COVID-19 test. Approval by Health Canada means that tests can now be shipped to Spartan’s federal and provincial government partners starting immediately.

Spartan’s test consists of a portable DNA analyzer called the Spartan Cube, which is the size of a coffee cup. The Cube performs the test with Spartan’s COVID-19 test cartridges and proprietary swabs, manufactured in Ottawa. The automated test can be operated by non-laboratory personnel in settings such as airports, border crossings, doctors’ offices, pharmacies, clinics, and remote communities.

“We are grateful to the Government of Canada for working closely with us to expedite the review and approval process,” says Paul Lem, M.D., CEO of Spartan Bioscience. “We are ready to start shipping our portable COVID-19 test to the federal and provincial governments, and to make them widely available to Canadians. 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.”

Spartan’s test was developed with funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP).

Spartan’s technology is currently in use by expert organizations such as the Centers for Disease Control (CDC), the New York State Department of Health, and Mayo Clinic. It has been published in prestigious medical journals including The Lancet and The New England Journal of Medicine. Spartan’s technology has regulatory approvals worldwide, including FDA 510(k), European CE IVD Mark, and Health Canada.

COVID-19 has had a huge global impact, with the virus progressing at an alarming rate. As a leading biotechnology company with a platform technology, bio teams, bio facilities and manufacturing, Spartan is looking into how it can quickly contribute to the health efforts worldwide.

We are currently investigating how our rapid, sample-to-result DNA testing platform can be used to detect the COVID-19 virus in under an hour.

Spartan’s diagnostic platform is a CE IVD approved DNA analyzer. Its size and unique ability to go directly from sample to result from non-technical staff would be ideal for fast and portable detection of COVID-19 because it can be deployed in non-aboratory settings such as airports, cruise ships, military bases, and other critical points of entry. The CDC has developed a COVID-19 DNA test and Spartan is currently exploring how to perform the test on its platform.