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.
She said she personally would not use the original lime-green kit. “[If] I want to visit my grandma who is 90 in a nursing care home,” she explained, “I wouldn’t choose this.”
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.
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.
This graphic lists studies by or funded by government health ministries connected with Health Canada’s mandatory foreign risk reporting program in fall 2020 and early winter 2021. To see the British study, search for ‘Comparative performance of SARS-CoV-2 lateral flow antigen tests and association with detection of infectious virus in clinical specimens: a single-centre laboratory evaluation study,’ published in The Lancet Microbe, June 2021. To see the German study, search for ‘Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021,’ published in Eurosurveillance, November 2021.
Deepak Sharma/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
The location of BTNX’s office in Markham, Ontario shown in this picture from August 2020. Global News.
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.
“All COVID-19 tests […] are supported by scientific evidence demonstrating that they consistently met standards to provide accurate and reliable results,” the ministry stated.
Trust a positive result from the test kit, but not a negative one
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.
Burlington, Ont., resident Janet Foley, holding a photo of her mother, Marilynne Gough, who died from a COVID-19 infection in January 2022.
Global News
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.”
To share any tips you may have about federal procurement, please contact patti.sonntag@globalnews.ca
MELBOURNE, Australia (AP) — The Australian government announced on Thursday what it described as world-leading legislation that would institute an age limit of 16 years for children to start using social media, and hold platforms responsible for ensuring compliance.
“Social media is doing harm to our kids and I’m calling time on it,” Prime Minister Anthony Albanese said.
The legislation will be introduced in Parliament during its final two weeks in session this year, which begin on Nov. 18. The age limit would take effect 12 months after the law is passed, Albanese told reporters.
The platforms including X, TikTok, Instagram and Facebook would need to use that year to work out how to exclude Australian children younger than 16.
“I’ve spoken to thousands of parents, grandparents, aunties and uncles. They, like me, are worried sick about the safety of our kids online,” Albanese said.
The proposal comes as governments around the world are wrestling with how to supervise young people’s use of technologies like smartphones and social media.
Social media platforms would be penalized for breaching the age limit, but under-age children and their parents would not.
“The onus will be on social media platforms to demonstrate they are taking reasonable steps to prevent access. The onus won’t be on parents or young people,” Albanese said.
Antigone Davis, head of safety at Meta, which owns Facebook and Instagram, said the company would respect any age limitations the government wants to introduce.
“However, what’s missing is a deeper discussion on how we implement protections, otherwise we risk making ourselves feel better, like we have taken action, but teens and parents will not find themselves in a better place,” Davis said in a statement.
She added that stronger tools in app stores and operating systems for parents to control what apps their children can use would be a “simple and effective solution.”
X did not immediately respond to a request for comment on Thursday. TikTok declined to comment.
The Digital Industry Group Inc., an advocate for the digital industry in Australia, described the age limit as a “20th Century response to 21st Century challenges.”
“Rather than blocking access through bans, we need to take a balanced approach to create age-appropriate spaces, build digital literacy and protect young people from online harm,” DIGI managing director Sunita Bose said in a statement.
More than 140 Australian and international academics with expertise in fields related to technology and child welfare signed an open letter to Albanese last month opposing a social media age limit as “too blunt an instrument to address risks effectively.”
Jackie Hallan, a director at the youth mental health service ReachOut, opposed the ban. She said 73% of young people across Australia accessing mental health support did so through social media.
“We’re uncomfortable with the ban. We think young people are likely to circumvent a ban and our concern is that it really drives the behavior underground and then if things go wrong, young people are less likely to get support from parents and carers because they’re worried about getting in trouble,” Hallan said.
Child psychologist Philip Tam said a minimum age of 12 or 13 would have been more enforceable.
“My real fear honestly is that the problem of social media will simply be driven underground,” Tam said.
Australian National University lawyer Associate Prof. Faith Gordon feared separating children from there platforms could create pressures within families.
Albanese said there would be exclusions and exemptions in circumstances such as a need to continue access to educational services.
But parental consent would not entitle a child under 16 to access social media.
Earlier this year, the government began a trial of age-restriciton technologies. Australia’s eSafety Commissioner, the online watchdog that will police compliance, will use the results of that trial to provide platforms with guidance on what reasonable steps they can take.
Communications Minister Michelle Rowland said the year-long lead-in would ensure the age limit could be implemented in a “very practical way.”
“There does need to be enhanced penalties to ensure compliance,” Rowland said.
“Every company that operates in Australia, whether domiciled here or otherwise, is expected and must comply with Australian law or face the consequences,” she added.
The main opposition party has given in-principle support for an age limit at 16.
Opposition lawmaker Paul Fletcher said the platforms already had the technology to enforce such an age ban.
“It’s not really a technical viability question, it’s a question of their readiness to do it and will they incur the cost to do it,” Fletcher told Australian Broadcasting Corp.
“The platforms say: ’It’s all too hard, we can’t do it, Australia will become a backwater, it won’t possibly work.’ But if you have well-drafted legislation and you stick to your guns, you can get the outcomes,” Fletcher added.
TOKYO (AP) — A robot that has spent months inside the ruins of a nuclear reactor at the tsunami-hit Fukushima Daiichi plant delivered a tiny sample of melted nuclear fuel on Thursday, in what plant officials said was a step toward beginning the cleanup of hundreds of tons of melted fuel debris.
The sample, the size of a grain of rice, was placed into a secure container, marking the end of the mission, according to Tokyo Electric Power Company Holdings, which manages the plant. It is being transported to a glove box for size and weight measurements before being sent to outside laboratories for detailed analyses over the coming months.
Plant chief Akira Ono has said it will provide key data to plan a decommissioning strategy, develop necessary technology and robots and learn how the accident had developed.
The first sample alone is not enough and additional small-scale sampling missions will be necessary in order to obtain more data, TEPCO spokesperson Kenichi Takahara told reporters Thursday. “It may take time, but we will steadily tackle decommissioning,” Takahara said.
Despite multiple probes in the years since the 2011 disaster that wrecked the. plant and forced thousands of nearby residents to leave their homes, much about the site’s highly radioactive interior remains a mystery.
The sample, the first to be retrieved from inside a reactor, was significantly less radioactive than expected. Officials had been concerned that it might be too radioactive to be safely tested even with heavy protective gear, and set an upper limit for removal out of the reactor. The sample came in well under the limit.
That’s led some to question whether the robot extracted the nuclear fuel it was looking for from an area in which previous probes have detected much higher levels of radioactive contamination, but TEPCO officials insist they believe the sample is melted fuel.
The extendable robot, nicknamed Telesco, first began its mission August with a plan for a two-week round trip, after previous missions had been delayed since 2021. But progress was suspended twice due to mishaps — the first involving an assembly error that took nearly three weeks to fix, and the second a camera failure.
On Oct. 30, it clipped a sample weighting less than 3 grams (.01 ounces) from the surface of a mound of melted fuel debris sitting on the bottom of the primary containment vessel of the Unit 2 reactor, TEPCO said.
On Thursday, the gravel, whose radioactivity earlier this week recorded far below the upper limit set for its environmental and health safety, was placed into a safe container for removal out of the compartment.
The sample return marks the first time the melted fuel is retrieved out of the containment vessel.
Fukushima Daiichi lost its key cooling systems during a 2011 earthquake and tsunami, causing meltdowns in its three reactors. An estimated 880 tons of fatally radioactive melted fuel remains in them.
The government and TEPCO have set a 30-to-40-year target to finish the cleanup by 2051, which experts say is overly optimistic and should be updated. Some say it would take for a century or longer.
Chief Cabinet Secretary Yoshimasa Hayashi said there have been some delays but “there will be no impact on the entire decommissioning process.”
No specific plans for the full removal of the fuel debris or its final disposal have been decided.
TORONTO – The Professional Women’s Hockey League has revealed the jersey designs for its six newly named teams.
Each PWHL team operated under its city name, with players wearing jerseys featuring the league’s logo in its inaugural season before names and logos were announced last month.
The Toronto Sceptres, Montreal Victoire, Ottawa Charge, Boston Fleet, Minnesota Frost and New York Sirens will start the PWHL’s second season on Nov. 30 with jerseys designed to reflect each team’s identity and to be sold to the public as replicas.
Led by PWHL vice-president of brand and marketing Kanan Bhatt-Shah, the league consulted Creative Agency Flower Shop to design the jerseys manufactured by Bauer, the PWHL said Thursday in a statement.
“Players and fans alike have been waiting for this moment and we couldn’t be happier with the six unique looks each team will don moving forward,” said PWHL senior vice president of business operations Amy Scheer.
“These jerseys mark the latest evolution in our league’s history, and we can’t wait to see them showcased both on the ice and in the stands.”
Training camps open Tuesday with teams allowed to carry 32 players.
Each team’s 23-player roster, plus three reserves, will be announced Nov. 27.
Each team will play 30 regular-season games, which is six more than the first season.
Minnesota won the first Walter Cup on May 29 by beating Boston three games to two in the championship series.
This report by The Canadian Press was first published Nov. 7, 2024.
