An instant test importer secured about $2 billion in federal contracts in 2021 and 2022, despite offering regulators incomplete knowledge about its product’s accuracy, Global News found.
A year-long investigation into federal procurement found that BTNX, a small provider of immediate tests discovered outside Toronto, had removed dozens of specimens or samples from a study it had submitted to Health Canada. This evaluation showed how well the company performs. check detected COVID-19.
The deletions made BTNX’s check more reliable and delicate than it was, according to researchers consulted via Global News.
Read about Global News’ investigation here.
The device is capable of detecting the virus in the most contagious users, but the effects of major regulators’ assessment systems mean that BTNX control is far less reliable in all other cases.
This obvious flaw meant that the verification kit was more likely to produce false-negative results, which many experts believed put Canadians’ lives at risk.
“I think it’s outrageous that the public wasn’t as aware of the discrepancies in the evidence that had real-world implications,” said Jillian Kohler, director of the World Health Organization’s Collaborating Centre for Health Governance, Transparency and Accountability at the University of Toronto.
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 emerging COVID-19 infections and the emergence of new variants, many may still have the original lime-green kits coded COV-19C25 in their homes. Some pharmacies, schools and daycares still distribute them.
Prior to the pandemic, BTNX founded one of its developing resources as a source of harm relief revenue at a retail store in Markham, Ontario: promoting kits that other people use to search for illicit drugs for fatal ingredients like fentanyl.
Despite the company’s lack of express expertise in infectious diseases, this outsider has become the country’s leading provider of immediate testing during the pandemic. The federal government awarded BTNX a series of 15 contracts that have become the largest procurement contract of the COVID era.
These products, imported from China, are the passports that Canadians relied on when fitness ministries ended lockdowns and social distancing restrictions. People used the controls to check themselves before returning to their workplaces, sending their children to school, meeting with friends, and visiting loved ones in long-term care facilities.
BTNX told Global News that it provided Health Canada or the Canadians with erroneous data about its test.
“We have acted with integrity and transparency, and have manufactured and distributed our immediate COVID-19 tests in accordance with Health Canada and foreign standards,” BTNX attorney Richard Dearden of Gowling WLP (Canada) wrote on behalf of the company.
Global News discovered the study, which was published as part of a broader investigation into public procurement practices. Following discrepancies in BTNX executives’ statements about their company’s business activities in a November 2022 interview, Global tracked its global sales, examining regulatory filings, contracts, court documents, business filings, and even commands contained in check kits.
The investigation found that BTNX came from Assure Tech, a Chinese manufacturer, which featured it to suppliers on its website. Global News received the original evaluation of the device through Assure Tech and the study published through BTNX at medical sources in Chile and Germany.
It was not immediately apparent that the two tests were identical. Some main points were changed from the BTNX edition, but the remaining data is identical. (To view the data, click here).
Leading researchers have called BTNX’s removals “unethical” and “dangerous. “
“The erasure of knowledge is a violation of all the principles of the studies,” said Dr. Harris. 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.
She advised her government not to buy it. Canada, however, bought in.
Reviewing the test, Baro believed he was reading a product from a British supplier, not knowing that his test would have an effect on Canadians, he said. But Global News discovered that BTNX had sold the tests to the British company.
Unbeknownst to Baro at the time, researchers applying for the UK and German governments were reading the same kit in late 2020 and early 2021.
Many governments around the world have evaluated immediate testing with the same method. Some have published the effects so consumers know which tests to buy.
The British and German teams found that the BTNX test reliably detected the most contagious cases of COVID-19.
Health Canada’s evaluation revealed results. In their report, lab technicians called the BTNX device “the least delicate test. “
Such comparisons between a company’s personal examination and the regulator’s assessment “do not yield other results,” Baro wrote to Global News.
Dr. Larissa Matukas, chief of the Division of Microbiology at Unity Health Toronto, St. Louis. John’s. Michael’s Hospital, said in a recent interview that the differences between knowledge through BTNX to Health Canada in the fall of 2020 and the effects of regulators at that time were concerning.
“In general, we would say it’s unacceptable,” he said, noting that “control is not smart enough to let us know that an individual is contagious. “
Reacting to questions from Global News, BTNX described its tests as “a reliable tool for Canadians. “
With respect to the suppressed samples, Attorney Dearden wrote on behalf of BTNX that the U. S. fitness regulator has not been able to do so. According to the U. S. Food and Drug Administration, the U. S. Food and Drug Administration is “moving towards” other rules about the types of samples to be included in the studies, which “BTNX has also done. “”
However, the FDA did not replace this guideline until a year later, in October 2021. When Global News asked BTNX why it got rid of the samples before the FDA superseded its guidelines, it did not respond.
Dearden denied that BTNX replaced in the studio: “BTNX made no changes,” he wrote. “
When asked about the Canadian, British and German results, Dearden said the German Fitness Ministry used samples that “did not reflect as it should reflect the efficacy of the tests. “
Cautioning that Global does not “select” “less significant” effects, BTNX instead cited the overall effects of studies it said were conducted in Pakistan, Croatia and Mexico. BTNX declined to comment on the data.
For its part, Health Canada stated that there is no explanation for questioning the clinical integrity of the studies submitted through BTNX.
The data provided through BTNX to Canadians about the device is accurate, according to the regulator’s response, as long as Canadians respect all the instructions in the fine print of the green kit, in addition to verifying the effects with a PCR test, performed in a laboratory.
Kohler, director of the WHO Centre at the University of Toronto, explained why the federal government awarded contracts to BTNX in the first place.
“The question is, what does this say about the Canadian government? Is it incompetence?”
BTNX’s adventure to secure government contracts began in the early spring of 2020 with a marketing and public relations crusade in the face of a desperate medical shortage of check-up kits.
As Canadians sheltered in makeshift open-air, bloodless COVID-19 testing centers, the government scrambled to find basic lab supplies.
BTNX claimed to have the solution.
Mitch Pittaway, the company’s chief financial officer, allegedly told CTV at the time that his company wanted to sell its “ultra-high-accuracy” out-of-the-box test for detecting COVID-19 antibodies in Canada. This first 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 CBC, pitching his company as a response to the government’s stated desire to produce medical supplies in the country.
The BTNX kit is not easy to distinguish from the one submitted by a handful of other Canadian vendors, who bought them all from Assure Tech in China.
A B C. La ophthalmologist took over BTNX, lobbying doctors to ask the government to approve it, and in an interview with CTV, allegedly referred to the company’s product as 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 have defended the manufacturers.
On April 29, 2020, Opposition Leader Andrew Scheer told Prime Minister Justin Trudeau in the House of Commons that Health Canada approved the BTNX antibody test.
Trudeau, in turn, praised BTNX as “an innovative Canadian company that had moved forward with a world-class product.”
Trudeau warned, however, that Health Canada would approve products that prove to be safe.
This marked a watershed moment for BTNX.
The doors have begun to open.
University researchers collaborating with BTNX implemented a federal investment in May 2020 to design and engineer an immediate check reader as a component of an educational project. The request was approved.
Officials from Innovation, Science and Economic Development Canada invited the company to enroll in a federal program to help small businesses grow quickly.
But the market had already changed. Five days before Trudeau and Scheer faced BTNX, the WHO warned that antibody tests were unreliable. Governments have scrambled to conduct antigen tests that can detect the virus itself.
In a request to Health Canada in October 2020, BTNX submitted impressive estimates on the reliability of a novel COVID-19 antigen that had been developed by its Chinese supplier, Assure Tech.
BTNX presented superior estimates of kit reliability compared to Assure Tech in its separate application.
With the country locked down and the economy paralyzed, the federal government’s procurement team struggled to obtain and acquire immediate evidence. Even with a multimillion-dollar budget, cash didn’t matter. Many other countries have faced the same daunting challenge.
Under the leadership of two successive fitness ministers, first Patty Hajdu and then Jean-Yves Duclos, Canadian officials placed almost all of their bets on BTNX in 2021 and 2022, awarding 15 contracts, according to Global News, around $2 billion.
“The Government of Canada has many points in deciding on immediate cheque providers,” the branch wrote in reaction to questions about the published study. “BTNX met those criteria to a sufficient extent.
Global News’ reports raise questions about next steps for Health Canada, BTNX, and Canadians who may still have a few boxes of VOC-19C25 in their medicine cabinets.
During the holiday season, if you have symptoms consistent with COVID-19 but get a negative kit result, Dr. Banerji advises you to be careful.
A positive result can be trusted, but not a negative one, she said.
BTNX and Health Canada in their positions.
Dearden warned that he could take legal action against Global News if it published the article, saying it would “harm a Canadian company identified as a world leader in immediate testing and other diagnostics. “
When Global News asked Health Canada if it intended to determine whether BTNX had submitted accurate data in its application to sell the kit, it responded directly.
Spokesman Mark Johnson wrote: “There are currently no plans to reassess the licensure of this medical device.”
People who have lost loved ones during the pandemic may have other 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 detect the virus on a layover at his mother’s home before Omicron entered the home. She said she and the staff at her mother’s long-term care home deserve the responsibility of Health Canada and BTNX.
“We accept it as true with any of those organizations,” he said.
Foley described how, during the pandemic years, she and staff followed Health Canada’s recommendations and commands presented through medical source companies.
Even in her mother’s best moments, she and her mother followed those guidelines.
“I’ve spent the last few days with my mom dressed in full personal protective gear,” Foley wrote, “gloves in hand. “
To find out the percentage of suggestions you might have about federal procurement, contact patti. sonntag@globalnews. ca.