Health Canada ignored warning signs before Ottawa spent billions on BTNX rapid tests

Health Canada ignored critical warnings about a rapid-test supplier before approving its COVID-19 kits for distribution nationwide, Global News has found.

A year-long Global News investigation into federal procurement revealed that BTNX, a Toronto-area rapid-test supplier that buys the devices from China, deleted dozens of specimens, or samples, from a study it submitted to Health Canada in October 2020. Deleting the specimens increased the estimate of the rapid test’s ability to detect the virus.

In October 2020, BTNX submitted an application to Health Canada as it sought approval to sell its rapid test for COVID-19. One of the studies in the package was a study that suggested the test would detect 94.55 per cent of infections, among people who had symptoms for less than 14 days.

However, two months earlier, BTNX told authorities in Peru the same test detected 80.2 per cent of infections overall, according to records that government published online.

The lower detection rate of 80.2 per cent of infections is the estimate that the kit’s Chinese manufacturer, Assure Tech, gave to every business selling the test worldwide. It was based on a study of the test’s ability to detect the virus carried out at two health-care facilities near the company’s Hangzhou headquarters.

Though an assistant deputy minister at Health Canada had already flagged possible issues with another BTNX application, federal employees reviewing BTNX’s file did not challenge the company about this improvement or ask for an explanation, according to correspondence Global News obtained via freedom of information request.

BTNX admitted that it had deleted specimens. The company “worked with the data provided to us,” BTNX wrote to Global News in December 2023,