Ottawa company’s rapid COVID-19 test approved by Health Canada

Health Canada has approved the authorization for a same-day COVID-19 test — a technology created by Ottawa company Spartan Bioscience.

The company made the announcement on its website on Saturday, saying its Spartan COVID-19 System, a rapid, on-site molecular diagnostic test for the qualitative detection of SARS-CoV-2, the virus causing COVID-19, has been approved to sell.

The company says the system will be able provide quality results to remote communities, industries and settings with limited lab access. This will help relieve the burden on overwhelmed healthcare systems, it adds.

“We want to thank our government and commercial partners for their patience, and trusting us to create a rapid RT-PCR testing option as part of Canada’s public health response,” said Roger Eacock, Chief Executive Officer of Spartan. “Readily deployed, rapid testing systems for COVID-19 are still needed across Canada, and will continue to be needed throughout 2021, even as vaccines begin to roll out.”

The test is performed by a health-care professional and provides on-site results within an hour.

The University of Ottawa Heart Institute was among the first testing locations during the company’s studies on the system.

““Accurate PCR-based rapid testing solutions are essential for improving patient outcomes and limiting the spread of disease in our communities,” said Dr. Derek So, Staff Cardiologist and Investigator Clinician at the Ottawa Heart Institute, who is leading a study to determine the role of point-of-care testing (POC) as a tool to improve care of COVID-19 patients and conserve resources. “This system enables healthcare teams to make important treatment decisions rapidly, precisely, and safely.”

With this authorization, Spartan says it is establishing a new domestic supply chain for rapid diagnosis that will allow Canadians to respond to current and future outbreaks.

Demands for the test will create over 250 Canadian jobs, Spartan estimates.

Production for the system has already started.

Shipments to federal and provincial governments, as well as Spartan’s commercial customers will also start immediately.

The company originally unveiled a rapid test for COVID-19 last spring but had to voluntarily recall it and perform additional studies after Health Canada expressed some reservations.

At the time, Spartan said Health Canada was concerned about the “efficacy of the proprietary swab” for the testing product.

The new version uses “any nasopharyngeal swab” rather than one of the company's own design, Health Canada said, and meets the agency's requirements for both safety and effectiveness.

– With files from Canadian Press