Vancouver company gets emergency U.S. approval for rapid COVID-19 test, now awaits Health Canada approval

January 24, 2021 update: This company’s rapid tests have not yet been approved by the FDA or Health Canada. Clinical trial evaluations are continuing.

BY PAMELA FAYERMAN

After being granted emergency use authorization by the Food and Drug Administration (FDA) to market its 15-minute COVID-19 test in the United States, a Vancouver company is now awaiting Health Canada approval.

The handheld rapid COVID-19 test is based on research, development and validation experiments conducted in Brazil; it is similar to a pregnancy assay but it uses a drop of blood instead of urine.

The Vancouver company, Victory Square Health, is focused on disease detection test kits. It has also developed an ELISA (enzyme-linked immunosorbent assay) blood test that can process 96 COVID samples at the same time, with results ready about three hours after specimen collection. Both tests are intended to indicate if someone is currently positive or whether they have antibodies that would suggest they were infected in the past.

Victory Square Health, a subsidiary of the publicly traded, venture capital company called Victory Square Technologies, will partner with others to provide companies with on-site testing teams, medical professionals, lab analysis, and a digital health passport containing secure data showing testing date, time, and results.

The company hopes to offer private test services to companies, border agencies, airports, public entertainment spaces, and individuals who choose not to get tested in the public health system, for whatever reason.

Health Canada approval won’t be swift; there are currently 98 other lab-based or point of care (rapid) tests developed in 14 countries waiting for such approvals to market their tests in Canada.  Last week, Health Canada finally announced deals with the first few companies for rapid tests.

Victory Square describes itself as a company that “builds, acquires, and invests in promising startups (like those in healthcare, insurance, gaming, and fintech), then provides the senior leadership and resources needed to fast-track growth.”

Its test received emergency use authorization by the FDA, European jurisdictions, and Brazil.

Brazil is expected to be the first country to receive orders for the ELISA test by the end of October while mass production for the U.S. orders is now getting underway.

Lab research assistants preparing ELISA COVID test in an affiliated VS Health lab in Brazil.

The company’s application to Health Canada is not yet listed on the government’s site but Peixoto said he could assure it has been done: “We submitted our application for Health Canada and we are following their process and approval process. Our team is working with Health Canada to address their follow up questions. Following Health Canada approval, we will take all the necessary steps to ensure we have complied with all provincial and federal guidelines.”

Peixoto was coy about the research and development that’s been done to bring the test to market and the experiments demonstrating how sensitive and specific the tests are.

“To get to the final version of the test, we went through a vast number of validations. We also performed an extensive clinical validation (for) accuracy of the test. These clinical studies usually are not published but they are the backbone of our regulatory submissions. All this information was sent with our Health Canada, FDA, ANVISA, and EU submissions. The instructions for use contains the data from the clinical validation, but we can only publish that after Health Canada approval. We are confident that our testing products will meet and exceed all guidelines from Health and Government agencies globally.”

Felipe Peixoto said the company is planning to manufacture five million test kits every month.

Even though the company has not been given Health Canada approval, and isn’t likely to get it anytime soon since there are 98 companies already in the queue, the company is already making announcements about tentative agreements with the Canadian Police Association to provide testing services to officers in 160 cities if an when it gains Health Canada approvals. It says it has also received advanced orders of millions of test kits from a Canadian supplier of personal protective equipment.