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.
More on Canada
BTNX admitted that it had deleted specimens. The company “worked with the data provided to us,” BTNX wrote to Global News in December 2023, making changes to “focus the data on the intended use of the product.”
In the wake of Global News’ reporting, BTNX added in a letter that the changes to the study were “based on the US FDA EUA template” and, in a press release, in “accordance with industry standards.”
The leap in the product’s accuracy was one of at least three red flags that Health Canada appears to have either missed or ignored as BTNX applied for a licence to sell the test kit in the fall of 2020. This included a warning from a senior Health Canada official about the veracity of the company’s public statements; data missing from a second study in BTNX’s application; and what researchers called elevated test results.
BTNX and Health Canada have stated that BTNX’s device works as promised, and regulators had all the information they required. Health Canada told Global News last month it will not re-examine BTNX’s licence to sell this test.
Dr. Stephen Ellis, member of Parliament for Cumberland-Colchester and the Conservative shadow minister for health, told Global News that his party will “hold the Liberals to account” and follow up on this “very serious concern regarding rapid test approvals.”
When Global News asked Mark Johnson, a Health Canada spokesman, what guidance applies to suppliers editing studies, he quoted the Food and Drugs Act.
“No person shall knowingly make a false or misleading statement,” he wrote.
Regardless, the federal government awarded BTNX a series of contracts in 2021 and 2022 that became Canada’s largest pandemic deal for medical supplies.
A wartime effort
When borders closed in the spring of 2020, with COVID-19 infections spreading, no vaccines, and entire nations in lockdown, workers at Health Canada and other federal offices faced a daunting task in finding the medical supplies Canada needed.
Government employees in Ottawa found themselves caught up in a global competition for rapid tests so fierce that a Health Canada official called it the “Hunger Games.”
Global News began looking into procurement while rapid test purchases were still underway. Federal ministries permitted some of the workers who evaluated rapid tests or procured them to participate in a rare group interview on the condition that Global News would not name employees or ask about contractors.
The interview took place in November 2022. Certain disparities in statements by BTNX executives a few weeks later led Global News to further investigate how and why BTNX received its contracts.
Six officials joined the interview, almost all of them at director level and above, in the interest of sharing their experiences during the public health emergency.
“The desperation can’t be captured in words,” recalled a senior official from the Public Health Agency of Canada.
Her voice broke as she shared the group’s fears that “we might not be able to get our hands on […] enough supply.”
All the world’s manufacturing plants were only able to meet a fraction of global needs. And Canadian officials could not match the purchasing power of their U.S. or European counterparts or the scale of their orders.
With few options, Canada turned inward. Prime Minister Justin Trudeau called on Canadian manufacturers to produce medical supplies, from face shields to ventilators.
Authorities preparing to launch mass screening pinned their hopes on a test manufactured by Spartan Bioscience, a company based in Ottawa. This DNA-based “lab-in-a-box” solution attempted to solve the problem of accuracy.
Health officials around the world had concerns about the reliability of the obvious alternative to lab tests, which were cheaply made rapid tests. In many markets these had never been regulated — and the World Health Organization would issue two warnings about them within the next six weeks.
Health Canada hired new employees, set up an emergency authorization process for health care equipment, and cut wait times on licences to sell medical supplies.
Over at Public Services and Procurement Canada, the invocation of the National Security Exemption empowered employees to skip most processes.
According to a CBC report published on April 12, 2020, exploring why Health Canada was lagging behind U.S. and European regulators, a BTNX executive said in an interview that the company was disappointed with the amount of time Health Canada was taking to approve its antibody test.
“We’ve seen the speed in which other, other health agencies around the world have been able to take these decisions,” BTNX’s CFO Mitch Pittaway said. “We think that Canada will hopefully be in a position to take a well-informed decision quite quickly.”
Pittaway was pitching an “antibody” test that detected the body’s reaction to the presence of COVID-19. Antigen tests, released soon afterward, detect the virus itself.
He noted that the company was selling the tests in the U.S. through an emergency program.
The next day, Pierre Sabourin, who was then an assistant deputy minister at Health Canada, flagged to Stephen Lucas, deputy minister, that he thought BTNX was misleading the public. Global News obtained correspondence between federal workers from a government website and freedom-of-information requests.
“Some manufacturers/importers claim falsely” that U.S. health authorities authorized their antibody tests for sale, Sabourin wrote. “For example, BTNX.”
At the time, the U.S. regulator was experimenting with pre-authorization sales, allowing rapid test suppliers to sell their products while they waited for officials to process their applications. BTNX was among that group.
BTNX’s application to Health Canada for authorization to sell the antibody test was “poor quality,” Sabourin added. The supplier had not submitted clinical data that backed up its claims, he wrote.
In response to Global News’ recent questions, BTNX wrote that it has always been transparent with regulators and the public.
Prime Minister Justin Trudeau addresses Canadians from Rideau Cottage in Ottawa on April 29, 2020, the same day that he spoke about rapid test suppliers in the House of Commons. THE CANADIAN PRESS/Sean Kilpatrick.
On April 29, 2020, in a House of Commons debate, Prime Minister Trudeau called BTNX an “innovative Canadian company that has moved forward with a world-class product.”
Health Canada did not respond to Global News’ questions about whether the ministry informed the Prime Minister’s Office about Sabourin’s concerns.
A priority application
Six months later, Spartan’s device had not proven reliable enough, according to Health Canada’s evaluation. And any obstacles to BTNX’s applications had seemingly vanished.
David Boudreau, director general of Health Canada, emailed Sabourin and Manon Bombardier, assistant deputy minister, on Oct. 14, 2020, to announce that, after discussions, BTNX had applied for authorization to sell an antigen test for COVID-19.
Given the emphasis on finding antigen tests, he wrote, Health Canada would review the file “in priority, as soon as possible.”
It is unclear why Health Canada prioritized BTNX’s application.
Assure Tech, BTNX’s supplier in China, had already applied separately to Health Canada for authorization to sell exactly the same product.
Sabourin did not reply to Boudreau in writing.
(Sabourin declined Global News’ request for comment. He retired in December 2021.)
Federal employees set to work.
In Winnipeg, workers at the National Microbiology Lab evaluated sample tests BTNX provided.
In Ottawa, an employee with a PhD in biochemistry supervised the examination of BTNX’s and Assure Tech’s nearly identical application packages, which workers paired together, according to federal records.
One of the evaluations in BTNX’s package, but not in Assure Tech’s, was the edited version of the study of the test’s ability to detect COVID-19.
It was not immediately apparent that the two documents described the same study. Global News’ analysis showed that in addition to omitting data, BTNX had renumbered the locations at which the evaluation took place and the specimens’ identifying numbers.
According to Health Canada, its employees did not notice that 132 out of the study’s original 348 specimens were missing and found no “reason to question [the studies’] scientific integrity.”
A quick scan of Canadian distributors’ websites would have shown that another business was marketing the same test to customers overseas with the overall 80.2 per cent sensitivity estimate. Yet in BTNX’s application to Health Canada, this figure jumped to nearly 95 per cent.
“There was no switching of sites,” the company’s spokesman wrote. BTNX provided a “reliable testing tool for Canadians.”
One of the changes involved removing “retrospective positives.” This refers to specimens that have been frozen.
BTNX said Canadian and U.S. health regulators recommended using fresh samples.
In fact, Health Canada advised the company that it could use frozen specimens in its correspondence with BTNX. The U.S. FDA said the same.
Global News’ examination of the data also revealed that BTNX did not delete all of the frozen specimens, only those that tested positive for COVID-19. Those deletions improved the outcome by nearly 10 percentage points.
Examining clinical studies posted to Health Canada’s website, Global News found that other rapid test suppliers used retrospective samples and described the results from unusable specimens.
In response to questions about whether editing data was common among Canadian rapid test companies, Cenk Ozkan, vice president of Artron Laboratories, based in Burnaby, B.C., told Global News that deleting data would risk “loss of credibility and legal actions.”
Health Canada, for its part, has defended its decision to approve BTNX’s application. The approval relied on the full package, a spokesman wrote in December, including a second study of the test’s sensitivity that was carried out in the United States and managed by Assure Tech, BTNX’s supplier.
Global News discovered BTNX’s version of this second study was different from Assure Tech’s as well.
This table presents all known versions of studies in Assure Tech’s and BTNX’s Health Canada applications.
Global News
The version of this second study Assure Tech submitted to Health Canada cited 230 specimens. BTNX’s version cited just 82, suggesting that an unknown person omitted the majority of the specimens.
Assure Tech did not respond to Global News’ requests for comment. BTNX told Global News that Assure Tech provided only 82 specimens to BTNX.
“AssureTech did not advise BTNX that it had additional specimens from another site or that it was submitting a broader study to Health Canada,” the company’s spokesman wrote on Jan. 5. Health Canada’s approval of the test for consumers relied on a third evaluation in the package, he stated.
The deletions have raised questions among Canadian researchers about why the regulator approved BTNX’s application.
Trudo Lemmens, a professor of health law and policy at the University of Toronto, said, “The fact that Health Canada didn’t see it or ignored it” suggests “regulatory failure.”
Lemmens called on the federal government to launch an investigation that allows for “scrutiny by independent researchers outside of government, outside of industry, to be able to see whether the data supports the claims.”
New questions about the application
In the November 2022 interview, a Health Canada official recalled federal workers’ sense of unity as he looked back on those terrible days.
“We were all rolling up our sleeves,” he said, “trying [to protect] the health and safety of Canadians.”
He and his colleagues seemed confident that they had weeded out less reliable suppliers.
“We came to realize which companies were able to have quality applications” with “data that would support the claims,” he explained to Global News.
Since Global News’ report was published, Health Canada has argued that the National Microbiology Laboratory’s evaluation of BTNX’s kit supported BTNX’s stated sensitivity.
A passer-by walked past a COVID-19 testing clinic in Montreal, Friday, Oct. 16, 2020.
THE CANADIAN PRESS/Ryan Remiorz
Global News obtained the NML’s results and the lab report, which called the device a “less-sensitive” test. The technicians attributed its lower outcomes to storage issues.
Unknown to Health Canada, researchers for the German, Spanish and British governments were separately reaching the same conclusion in the fall of 2020 and winter of 2021. (To learn more, you can read our Dec. 21 story online.)
Researchers Global News asked to review the data said the contrast between the governments’ results and the outcomes BTNX reported to Health Canada were eye-catching.
Dr. Larissa Matukas, head of the microbiology division at Unity Health Toronto, St. Michael’s Hospital, explained, “You’re not going to score 100 per cent […] all the time for every single patient.”
The ministry approved BTNX’s and Assure Tech’s applications on Feb. 19, 2021.
Over the next year and a half, the federal government bought 404 million test kits from BTNX for an estimated $2 billion. Global News’ reporting indicates that this was the biggest order any government placed with any supplier of Assure Tech’s device worldwide.
PHOENIX (AP) — Arizona voters have approved a constitutional amendment guaranteeing abortion access up to fetal viability, typically after 21 weeks — a major win for advocates of the measure in the presidential battleground state who have been seeking to expand access beyond the current 15-week limit.
Arizona was one of nine states with abortion on the ballot. Democrats have centered abortion rights in their campaigns since the U.S. Supreme Court overturned Roe v. Wade in 2022. Abortion-rights supporters prevailed in all seven abortion ballot questions in 2022 and 2023, including in conservative-leaning states.
Arizona for Abortion Access, the coalition leading the state campaign, gathered well over the 383,923 signatures required to put it on the ballot, and the secretary of state’s office verified that enough were valid. The coalition far outpaced the opposition campaign, It Goes Too Far, in fundraising. The opposing campaign argued the measure was too far-reaching and cited its own polling in saying a majority of Arizonans support the 15-week limit. The measure allows post-viability abortions if they are necessary to protect the life or physical or mental health of the mother.
Access to abortion has been a cloudy issue in Arizona. In April, the state Supreme Court cleared the way for the enforcement of a long-dormant 1864 law banning nearly all abortions. The state Legislature swiftly repealed it.
Voters in Arizona are divided on abortion. Maddy Pennell, a junior at Arizona State University, said the possibility of a near-total abortion ban made her “depressed” and strengthened her desire to vote for the abortion ballot measure.
“I feel very strongly about having access to abortion,” she said.
Kyle Lee, an independent Arizona voter, does not support the abortion ballot measure.
“All abortion is pretty much, in my opinion, murder from beginning to end,” Lee said.
The Civil War-era ban also shaped the contours of tight legislative races. State Sen. Shawnna Bolick and state Rep. Matt Gress are among the handful of vulnerable Republican incumbents in competitive districts who crossed party lines to give the repeal vote the final push — a vote that will be tested as both parties vie for control of the narrowly GOP-held state Legislature.
Both of the Phoenix-area lawmakers were rebuked by some of their Republican colleagues for siding with Democrats. Gress made a motion on the House floor to initiate the repeal of the 1864 law. Bolick, explaining her repeal vote to her Senate colleagues, gave a 20-minute floor speech describing her three difficult pregnancies.
While Gress was first elected to his seat in 2022, Bolick is facing voters for the first time. She was appointed by the Maricopa County Board of Supervisors to fill a seat vacancy in 2023. She has not emphasized her role in the repeal vote as she has campaigned, instead playing up traditional conservative issues — one of her signs reads “Bolick Backs the Blue.”
Voters rejected a measure to eliminate retention elections for state Superior Court judges and Supreme Court justices.
The measure was put on the ballot by Republican legislators hoping to protect two conservative justices up for a routine retention vote who favored allowing the Civil War-era ban to be enforced — Shawnna Bolick’s husband, Supreme Court Justice Clint Bolick, and Justice Kathryn Hackett King. Since the measure did not pass, both are still vulnerable to voter ouster, though those races hadn’t been decided by early Wednesday morning.
Under the existing system, voters decide every four to six years whether judges and justices should remain on the bench. The proposed measure would have allowed the judges and justices to stay on the bench without a popular vote unless one is triggered by felony convictions, crimes involving fraud and dishonesty, personal bankruptcy or mortgage foreclosure.
OMAHA, Neb. (AP) — Nebraska voters supported a measure Tuesday that enshrines the state’s current ban on abortions after the 12th week of pregnancy in the state constitution, and they rejected a competing measure that sought to expand abortion rights. Nebraska was the first state to have competing abortion amendments on the same ballot since the U.S. Supreme Court overturned Roe v. Wade in 2022, ending the nationwide right to abortion and allowing states to decide for themselves. The dueling measures were among a record number of petition-initiated measures on Nebraska’s ballot Tuesday.
What were the competing abortion measures?
A majority of voters supported a measure enshrining the state’s current ban on abortion after the first 12 weeks of pregnancy in the state constitution. The measure will also allow for further restrictions. Last year, the Legislature passed the 12-week ban, which includes exceptions for cases of rape and incest and to protect the life of the pregnant woman.
Voters rejected the other abortion measure. If they had passed it by a larger number of “for” votes than the 12-week measure, it would have amended the constitution to guarantee the right to have an abortion until viability — the standard under Roe that is the point at which a fetus might survive outside the womb. Some babies can survive with medical help after 21 weeks of gestation.
Abortion was on the ballot in several other states, as well. Coming into the election, voters in all seven states that had decided on abortion-related ballot measures since the reversal of Roe had favored abortion rights, including in some conservative states.
Who is behind the Nebraska abortion measures?
The 12-week ban measure was bankrolled by some of Nebraska’s wealthiest people, including Republican Sen. Pete Ricketts, who previously served as governor and donated more than $1.1 million. His mother, Marlene Ricketts, gave $4 million to the cause. Members of the Peed family, which owns publishing company Sandhills Global, also gave $1 million.
The effort was organized under the name Protect Women and Children and was heavily backed by religious organizations, including the Nebraska Catholic Conference, a lobbying group that has organized rallies, phone banks and community townhalls to drum up support for the measure.
The effort to enshrine viability as the standard was called Protect Our Rights Nebraska and had the backing of several medical, advocacy and social justice groups. Planned Parenthood donated nearly $1 million to the cause, with the American Civil Liberties Union, I Be Black Girl, Nebraska Appleseed and the Women’s Fund of Omaha also contributing significantly to the roughly $3.7 million raised by Protect Our Rights.
What other initiatives were on Nebraska’s ballot?
Nebraska voters approved two measures Tuesday that will create a system for the use and manufacture of medical marijuana, if the measures survive an ongoing legal challenge.
The measures legalize the possession and use of medical marijuana, and allow for the manufacture, distribution and delivery of the drug. One would let patients and caregivers possess up to 5 ounces (142 grams) of marijuana if recommended by a doctor. The other would create the Nebraska Medical Cannabis Commission, which would oversee the private groups that would manufacture and dispense the drug.
Those initiatives were challenged over allegations that the petition campaign that put them on the ballot broke election rules. Nebraska’s attorney general said supporters of the measures may have submitted several thousand invalid signatures, and one man has been charged in connection with 164 allegedly fraudulent signatures. That means a judge could still invalidate the measures.
Voters also opted Tuesday to repeal a new conservative-backed law that allocates millions of dollars in taxpayer money to fund private school tuition.
Finally, they approved a measure that will require all Nebraska employers to provide at least 40 hours of paid sick leave to their employees.
WASHINGTON (AP) — Voters in Missouri cleared the way to undo one of the nation’s most restrictive abortion bans in one of seven victories for abortion rights advocates, while Florida, Nebraska and South Dakota defeated similar constitutional amendments, leaving bans in place.
Abortion rights amendments also passed in Arizona, Colorado, Maryland and Montana. Nevada voters also approved an amendment, but they’ll need to pass it again it 2026 for it to take effect. Another that bans discrimination on the basis of “pregnancy outcomes” prevailed in New York.
The results include firsts for the abortion landscape, which underwent a seismic shift in 2022 when the U.S. Supreme Court overturned Roe v. Wade, a ruling that ended a nationwide right to abortion and cleared the way for bans to take effect in most Republican-controlled states.
They also came in the same election that Republican Donald Trump won the presidency. Among his inconsistent positions on abortion has been an insistence that it’s an issue best left to the states. Still, the president can have a major impact on abortion policy through executive action.
In the meantime, Missouri is positioned to be the first state where a vote will undo a ban on abortion at all stages of pregnancy, with an amendment that would allow lawmakers to restrict abortions only past the point of a fetus’ viability — usually considered after 21 weeks, although there’s no exact defined time frame.
But the ban, and other restrictive laws, are not automatically repealed. Advocates now have to ask courts to overturn laws to square with the new amendment.
“Today, Missourians made history and sent a clear message: decisions around pregnancy, including abortion, birth control, and miscarriage care are personal and private and should be left up to patients and their families, not politicians,” Rachel Sweet, campaign manager of Missourians for Constitutional Freedom, said in a statement.
Roughly half of Missouri’s voters said abortion should be legal in all or most cases, according to AP VoteCast, a survey of more than 2,200 of the state’s voters. But only about 1 in 10 said abortion should be illegal in all cases; nearly 4 in 10 said abortion should be illegal in most cases.
Bans remain in place in three states after votes
Florida, Nebraska and South Dakota became the first states since Roe was overturned where abortion opponents prevailed on a ballot measure. Most voters supported the Florida measure, but it fell short of the required 60% to pass constitutional amendments in the state. Most states require a simple majority.
The result was a political win for Gov. Ron DeSantis, a Republican with a national profile, who had steered state GOP funds to the cause. His administration has weighed in, too, with a campaign against the measure, investigators questioning people who signed petitions to add it to the ballot and threats to TV stations that aired one commercial supporting it.
Marjorie Dannenfelser, president of the national anti-abortion group SBA Pro-Life America, said in a statement that the result is “a momentous victory for life in Florida and for our entire country,” praising DeSantis for leading the charge against the measure.
The defeat makes permanent a shift in the Southern abortion landscape that began when the state’s six-week ban took effect in May. That removed Florida as a destination for abortion for many women from nearby states with deeper bans and also led to far more women from the state traveling to obtain abortion. The nearest states with looser restrictions are North Carolina and Virginia — hundreds of miles away.
“The reality is because of Florida’s constitution a minority of Florida voters have decided Amendment 4 will not be adopted,” said Lauren Brenzel, campaign director for the Yes on 4 Campaign said while wiping away tears. “The reality is a majority of Floridians just voted to end Florida’s abortion ban.”
In South Dakota, another state with a ban on abortion throughout pregnancy with some exceptions, the defeat of an abortion measure was more decisive. It would have allowed some regulations related to the health of the woman after 12 weeks. Because of that wrinkle, most national abortion-rights groups did not support it.
Voters in Nebraska adopted a measure that allows more abortion restrictions and enshrines the state’s current 12-week ban and rejected a competing measure that would have ensured abortion rights.
Other states guaranteed abortion rights
Arizona’s amendment will mean replacing the current law that bans abortion after the first 15 weeks of pregnancy. The new measure ensures abortion access until viability. A ballot measure there gained momentum after a state Supreme Court ruling in April found that the state could enforce a strict abortion ban adopted in 1864. Some GOP lawmakers joined with Democrats to repeal the law before it could be enforced.
In Maryland, the abortion rights amendment is a legal change that won’t make an immediate difference to abortion access in a state that already allows it.
It’s a similar situation in Montana, where abortion is already legal until viability.
The Colorado measure exceeded the 55% of support required to pass. Besides enshrining access, it also undoes an earlier amendment that barred using state and local government funding for abortion, opening the possibility of state Medicaid and government employee insurance plans covering care.
A New York equal rights law that abortion rights group say will bolster abortion rights also passed. It doesn’t contain the word “abortion” but rather bans discrimination on the basis of “pregnancy outcomes, and reproductive healthcare and autonomy.” Sasha Ahuja, campaign director of New Yorkers for Equal Rights, called the result “a monumental victory for all New Yorkers” and a vote against opponents who she says used misleading parental rights and anti-trans messages to thwart the measure.
The results end a win streak for abortion-rights advocates
Until Tuesday, abortion rights advocates had prevailed on all seven measures that have appeared on statewide ballots since the fall of Roe.
The abortion rights campaigns have a big fundraising advantage this year. Their opponents’ efforts are focused on portraying the amendments as too extreme rather than abortion as immoral.
Currently, 13 states are enforcing bans at all stages of pregnancy, with some exceptions. Four more bar abortion in most cases after about six weeks of pregnancy — before women often realize they’re pregnant. Despite the bans, the number of monthly abortions in the U.S. has risen slightly, because of the growing use of abortion pills and organized efforts to help women travel for abortion. Still, advocates say the bans have reduced access, especially for lower-income and minority residents of the states with bans.
The issue is resonating with voters. About one-fourth said abortion policy was the single most important factor for their vote, according to AP VoteCast, a sweeping survey of more than 110,000 voters nationwide. Close to half said it was an important factor, but not the most important. Just over 1 in 10 said it was a minor factor.
The outcomes of ballot initiatives that sought to overturn strict abortion bans in Florida and Missouri were very important to a majority of voters in the states. More than half of Florida voters identified the result of the amendment as very important, while roughly 6 in 10 of Missouri’s voters said the same, the survey found.
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Associated Press reporters Hannah Fingerhut and Amanda Seitz contributed to this article.
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This article has been corrected to reflect in the ‘other states’ section that Montana, not Missouri, currently allows abortion until viability.
