A rapid test importer landed an estimated $2 billion in federal contracts in 2021 and 2022, despite giving regulators incomplete data about its product’s accuracy, Global News has found.
A year-long investigation into federal procurement revealed that BTNX, a small rapid test supplier based outside Toronto, deleted dozens of specimens, or samples, from a study it submitted to Health Canada. That evaluation showed how well the company’s test detected COVID-19.
The deletions made BTNX’s test appear more reliable and sensitive than it really was, according to researchers Global News consulted.
The device could detect the virus in users who were the most contagious, but results from leading regulators’ evaluation programs indicate BTNX’s test was much less dependable in all other cases.
This apparent flaw meant the test kit was more likely to produce false-negative results which, many experts said, put Canadian lives at risk.
“I think it’s outrageous that the public wasn’t as aware of the discrepancies in the testings that had real-life implications,” said Jillian Kohler, director of the University of Toronto’s World Health Organization Collaborating Centre for Governance, Transparency and Accountability in the Pharmaceutical Sector.
Health Canada and the Public Health Agency of Canada bought 404 million tests from BTNX, which became ubiquitous during the pandemic.
Now, as Canadians gather for the holidays amid reports of an uptick of COVID-19 infections and the emergence of new variants, many may still have the original, lime-green kits with the code COV-19C25 in their homes. Some pharmacies, schools and daycares still distribute them.
Before the pandemic, BTNX was based in a business plaza in Markham, Ontario. One of its growing revenue streams involved harm reduction — selling kits people use to test illicit drugs for deadly substances like fentanyl.
Despite the company’s lack of specific expertise with infectious diseases, this underdog became the nation’s foremost rapid test supplier during the pandemic. The federal government awarded BTNX a series of 15 contracts that became the largest COVID-era supply deal.
These products, imported from China, became the passports Canadians depended on as health ministries ended lockdowns and social distancing restrictions. People used the tests to screen themselves before returning to workplaces, sending their kids off to school, meeting with friends, and visiting loved ones in long-term care facilities.
BTNX told Global News that it did not offer Health Canada or Canadians inaccurate information about its test.
”We have at all times operated with integrity and transparency, and have manufactured and distributed our COVID-19 rapid tests in accordance with Health Canada and international standards,” BTNX’s lawyer, Richard Dearden of Gowling WLP (Canada), wrote on the company’s behalf.
Global News uncovered the edited study as part of a larger investigation examining government procurement practices. Following up on discrepancies in statements BTNX executives made about their company’s business activities in a November 2022 interview, Global traced its worldwide sales, scrutinizing regulatory records, contracts, court documents, sales presentations and even the instructions in the test kits.
The investigation found that BTNX sourced its device from Assure Tech, a manufacturer in China, which offered it to distributors on its website. Global News obtained Assure Tech’s original evaluation of the device and BTNX’s edited study from medical supply websites in Chile and Germany.
It was not immediately apparent that the two assessments were the same. Some details in BTNX’s version had been changed, but the remaining data was identical. (To view the data, click here.)
Leading researchers called BTNX’s deletions “unethical” and potentially “dangerous.”
“Removal of data is really a violation of all research principles,” said Dr. Anna Banerji, an infectious disease specialist at the University of Toronto’s Dalla Lana School of Public Health.
Bàrbara Baro, a biomedical researcher at the Barcelona Institute for Global Health, studied the test on behalf of the Catalonian health system in early 2021. She found that it performed poorly at detecting the virus in people who were infectious but had no symptoms.
It was not a dependable screening tool, she added, particularly for people who have been vaccinated. And it would have to be re-evaluated for its ability to detect each new variant.
While reviewing the test, Baro believed she was studying a British supplier’s product, unaware that her study would impact Canadians, she said. But Global News found that BTNX sold the tests to the British company.
Also unbeknownst to Baro at the time, researchers working for the British and German governments were studying the same kit in late 2020 and early 2021.
Many governments around the world evaluated rapid tests with the same method. Some posted the results so that consumers could decide which tests to buy.
The British and the German teams found that BTNX’s test reliably detected only the most infectious COVID-19 cases.
Health Canada’s evaluation revealed similar results. In their report, lab technicians called BTNX’s device one of the “less-sensitive tests.”
Such comparisons between a company’s private study and the regulator’s evaluation “usually don’t get such different results,” Baro wrote to Global News.
Dr. Larissa Matukas, head of the microbiology division at Unity Health Toronto, St. Michael’s Hospital, said in a recent interview that the differences between the data BTNX gave to Health Canada in the fall of 2020 and the regulators’ results from that period were concerning.
“Typically we would say that’s unacceptable,” she said, indicating “the test is not good enough to be able to let us know that an individual is actually infectious.”
In response to Global News’ questions, BTNX described its tests as “a reliable testing tool for Canadians.”
With regards to the deleted specimens, lawyer Dearden wrote on BTNX’s behalf that the U.S. health regulator, the Food and Drug Administration, was “moving towards” different guidelines about which types of samples to include in studies, which “BTNX did as well.”
The FDA, however, did not change this guideline until a year later, in October 2021. When Global News asked BTNX why it had deleted samples before the FDA changed its guidelines, it did not reply.
Dearden denied that BTNX edited information within the study: “BTNX did not make any changes,” he wrote.
When asked about the Canadian, British and German results, Dearden said that the German health ministry used samples that “did not accurately reflect test efficacy.”
Warning that Global should not “cherry pick” results that were “less meaningful,” BTNX instead cited overall results from studies it said had taken place in Pakistan, Croatia and Mexico. BTNX declined to share the data.
For its part, Health Canada said it found no reason to question the scientific integrity of the studies BTNX submitted.
The information BTNX provided to Canadians about the device was accurate, according to the regulator’s response, as long as Canadians followed all of the fine-print instructions in the green kit, including verifying the results with a PCR test, which is performed at a lab.
Kohler, director of the WHO centre at the University of Toronto, asked why the federal government awarded contracts to BTNX in the first place.
“The question is, what does this say about the Canadian government?” she said. “Is this incompetence?”
How a Global News investigation into federal pandemic contracts unfolded
BTNX’s path to securing the government contracts began in the early spring of 2020 with a marketing and public relations campaign during the desperate medical shortages of test kits.
While Canadians were lining up in the cold outside makeshift COVID-19 testing centres, the federal government was scrambling to find basic laboratory supplies.
BTNX claimed it had the solution.
Mitch Pittaway, the company’s chief financial officer, reportedly told CTV at the time that his company wanted to sell its “very high accuracy” rapid test for antibodies to COVID-19 in Canada. This early test detected the body’s reaction to the virus.
Health Canada, he suggested, was standing in the way.
The company was already exporting “tens of thousands” of antibody tests to U.S. customers, Pittaway reportedly told the CBC, presenting his company as a solution to the federal government’s stated need to support domestic medical supply manufacturing.
In reality, BTNX’s kit was imported from China. BTNX’s kit was not easily distinguishable from the same one offered by a handful of other Canadian suppliers, all of whom bought them from Assure Tech in China.
An ophthalmologist in British Columbia took up BTNX’s fight, lobbying doctors to petition the government to approve the test and in an interview with CTV, she reportedly called the company’s product a “made in Canada” kit.
In the confusion, most Canadians likely had no notion that, under laws governing medical devices, a product’s importer may call itself its manufacturer, or that importing a test from abroad is a form of “manufacturing.”
Leaders on both sides of the aisle advocated for local manufacturers.
On April 29, 2020, Opposition leader Andrew Scheer told Prime Minister Justin Trudeau in the House of Commons that Health Canada should approve BTNX’s antibody test.
Trudeau, in turn, praised BTNX as “an innovative Canadian company that had moved forward with a world-class product.”
Trudeau cautioned, however, that Health Canada would only approve products proven to be safe.
That exchange marked a defining moment for BTNX.
Doors within the government began to open.
University researchers who partnered with BTNX applied for federal funding in May 2020 to design and engineer a rapid test reader as an academic project. The application was approved.
Officials at Innovation, Science and Economic Development Canada invited the company to join a federal program helping small businesses to scale up quickly.
But already the market had shifted. Five days before Trudeau and Scheer sparred over BTNX, the WHO warned that antibody tests were unreliable. Governments raced to find antigen tests, which detect the virus itself.
In an application to Health Canada in October 2020, BTNX submitted impressive estimates for the reliability of a new COVID-19 antigen test that its Chinese supplier, Assure Tech, had developed.
BTNX offered slightly higher estimates of the kit’s reliability than Assure Tech did in its separate application.
With the country in lockdown and the economy at a standstill, the federal government’s procurement team was struggling to source and purchase rapid tests. Even with a budget of billions of dollars, money didn’t count. Many other nations faced the same daunting challenge.
Under the leadership of two successive health ministers, first Patty Hajdu and then Jean-Yves Duclos, Canadian officials placed almost all of their bets with BTNX in 2021 and 2022, awarding 15 contracts Global News has calculated were worth approximately $2 billion.
“The Government of Canada considered many factors when selecting rapid test suppliers,” the ministry wrote in response to questions about the edited study. “BTNX met these criteria to a sufficient degree.
Global News’ reporting raises questions about the next steps for Health Canada, BTNX, and Canadians who may still have a few boxes of COV-19C25 in their medicine cabinets.
During the holiday season, if you have symptoms consistent with COVID-19 but get a negative result from the kit, Dr. Banerji advises caution.
A positive result can be trusted, but not a negative one, she said.
BTNX and Health Canada remain steadfast in their positions.
Dearden warned it may take legal action against Global News if it published this article, stating it will “damage a Canadian company that is recognized as a world leader in rapid tests and other diagnostics.”
When Global News asked Health Canada if it intended to investigate whether BTNX had submitted accurate information in its application to sell the kit, it did not respond directly.
Spokesman Mark Johnson wrote: “There are currently no plans to reassess the licensure of this medical device.”
People who lost loved ones during the pandemic may have further questions.
The government’s answer was insufficient for Janet Foley, a Burlington, Ont., resident who lost her 84-year-old mother, Marilynne Gough, during the first Omicron wave.
Foley had used the kits to screen for the virus when visiting her mother before Omicron got into the home. She said that she and the workers at her mother’s long-term care home deserved accountability from both Health Canada and BTNX.
“We put our faith in those two organizations,” she said.
Foley described how, during the pandemic years, she and the staff followed both Health Canada’s guidance and the instructions offered by medical supply companies.
Even in her mother’s last moments, she and her mother observed those guidelines.
“I spent the last days with my mother dressed in full PPE,” Foley wrote, “wearing gloves to hold her hand.”