Human milk offers a window into mammary gland function—and its links to infant growth

NYU Langone Health / NYU Grossman School of Medicine

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A study led by researchers at NYU Grossman School of Medicine identified shared molecular patterns in human milk that link maternal nutrition, mammary gland biology, and infant growth.

Researchers analyzed thousands of molecular measurements from human milk collected across three geographically and nutritionally diverse populations of mothers. They identified shared patterns in milk composition associated with both maternal nutritional status and infant growth, and asked whether these patterns could also provide insight into the mammary gland functional state.

Published online October 8 in the journal Science, the study examined this state, which involves three interconnected aspects of mammary gland function: milk synthesis and secretion, epithelial barrier and tissue remodeling, and immune and repair activity. Milk synthesis and secretion describe how mammary cells produce the components of milk and release them into milk; barrier and tissue-remodeling functions regulate what passes between the bloodstream and milk while reshaping the milk-producing tissue; and immune and repair activity helps protect the gland and restore tissue after stress or injury. 

By mapping molecular patterns in milk onto these biological processes, the researchers asked not only what is present in milk, but also what its composition may reveal about the function of the mammary gland that produces it.

“Human milk gives us a rare, non-invasive window into the biology of the lactating mammary gland,” said Liat Shenhav, PhD, senior author of the study and an assistant professor at NYU Grossman School of Medicine, with appointments in the Institute for Systems Genetics, the Department of Microbiology, and the Department of Obstetrics and Gynecology. “By looking at molecular patterns across diverse populations, we can begin to identify shared features of mammary function and understand how maternal nutritional and metabolic state relates to milk composition and infant growth.”

Despite its central role, how the functional state of the gland shapes milk composition—and how that variation relates to infant growth—remains poorly understood. Human milk contains thousands of nutrients, metabolites, proteins, immune factors, and other molecules, but research has often examined these components one at a time rather than as an integrated biological system. 

Across 1,543 human milk samples from three cohorts in Canada, Pakistan and Burkina Faso, the researchers combined multiple molecular layers—including metabolites, proteins, micronutrients (e.g., vitamins), macronutrients (e.g., carbohydrates), and human milk oligosaccharides — with growth data and computational approaches including machine learning, a form of artificial intelligence. 

In two randomized nutritional trials, maternal supplementation promoted recovery or stability among infants at higher risk for poor growth. Multi-omic analyses – which integrate information across several molecule types, such as proteins and metabolites, to provide a complete picture of a biological system - also revealed a shared pattern of milk composition associated with both maternal supplementation and infant growth.

The researchers then examined which molecules most consistently contributed to these shared nutrition-growth patterns. Their analysis identified seven candidate biomarkers linked to maternal nutritional status, infant growth and biological programs related to mammary gland function. Together, these markers captured aspects of mammary biology that extend beyond established measures of blood-milk barrier permeability.

Four of the markers—C2, C3, C4 and C5—were short-chain acylcarnitines, molecules that help cells process nutrients for energy. The remaining three were lysine, an amino acid; 6′ sialyllactose, a human milk oligosaccharide; and selenium, a mineral. Together, the seven biomarkers captured complementary aspects of mammary biology, including milk synthesis, tissue remodeling, and immune response activity.

Short-chain acylcarnitines showed the strongest links across mammary functional domains, with C5 emerging as a particularly prominent signal. Higher C5 levels were associated with reduced milk synthesis signatures and with biological patterns related to tissue remodeling and immune activity.

Because C5 emerged as a central metabolic signal, the researchers examined nutritional factors that might help explain variation in acylcarnitine levels. Acylcarnitine metabolism depends on coenzyme A (CoA), a central molecule in energy and lipid metabolism synthesized from pantothenic acid, or vitamin B5. Drawing on associations across cohorts and established metabolic biology, the researchers propose that low vitamin B5 availability may constrain CoA-dependent metabolism and contribute to altered acylcarnitine profiles, including accumulation of C5.

“Our findings demonstrate the intimate link between maternal nutrition, metabolic health and mammary function, highlighting the importance of an integrative approach to supporting maternal and infant health,” said first author Dr. April Jauhal of the Shenhav lab at NYU Grossman School of Medicine. "One plausible route linking maternal nutrition to mammary metabolism in our data is via the pantothenic-CoA-C5 metabolic pathway, and we are currently investigating the functional role of this pathway in mammary biology and lactation.”

Because human milk can be collected repeatedly, it provides a non-invasive way to study mammary gland biology over time. Viewing milk as a window into mammary gland biology also places lactation within a broader continuum of maternal physiology that begins during pregnancy. During gestation, the mammary gland undergoes extensive hormonal differentiation, tissue and immune remodeling, and metabolic programming, while its major functional phenotype—lactation—becomes apparent only after delivery.

In this sense, the mammary gland can be viewed as a postnatal maternal-infant interface: an organ programmed during pregnancy that subsequently connects maternal biology and nutrition with the developing infant. Like the placenta during pregnancy, it sits at a critical interface between mother and child—but human milk provides a way to study that interface repeatedly and non-invasively after delivery.

Building on this work, the Shenhav Lab is now developing an integrated computational and experimental framework to test potential nutritional bottlenecks that may constrain mammary metabolism and milk production, including the vitamin B5–coenzyme A–C5 pathway. The lab is also studying colostrum and transitional milk to understand how mammary functional states emerge during the transition from pregnancy to mature lactation, and whether early molecular changes in milk reflect the emergence of mammary metabolic, barrier, and secretory function.

The study is one of two complementary papers published in Science arising from the International Milk Composition (IMiC) Consortium, an international research effort conducted in collaboration with Meghan Azad of the University of Manitoba and funded by the Gates Foundation.

IMiC brought together more than 1,000 mother-infant pairs and profiled more than 25,000 molecular features in human milk. While the NYU Grossman School of Medicine-led study asked what milk composition can reveal about mammary gland function and its relationship with infant growth, the companion study asked a complementary question: Which components of human milk can be changed through maternal nutrition?

The companion study found that supplementation during lactation increased several B vitamins in milk, while many other milk components remained comparatively stable. Together, these studies aim to determine how maternal nutritional and metabolic state during pregnancy and postpartum shapes mammary function, how that state is reflected in human milk, and how these processes relate to infant development.

“The studies show that human milk is neither fixed nor simply a reflection of what a mother eats,” said Dr. Shenhav. “Some components respond to maternal nutrition, while others remain stable or appear to reflect broader biological states within the mammary gland. Understanding that distinction is essential if we want to design interventions that meaningfully support maternal and infant health.”

“Ultimately, we want to understand milk in the context of the biology that produces it,” said Dr. Shenhav. “The mammary gland sits at a critical interface between maternal physiology and the developing infant. By understanding how maternal metabolism influences mammary function and milk composition, we can begin to uncover the biological pathways linking maternal nutritional status with infant growth.”

The study was funded by the Gates Foundation (INV-001734, OPP1179727, and OPP1175213), the National Institutes of Health grant DP2AI185753, the Canadian Institutes of Health Research, the Allergy, Genes and Environment Network, Networks of Centres of Excellence (AllerGen NCE), Health Canada, Environment Canada, the Canada Mortgage and Housing Corporation, the Vital Pakistan Trust; the Burroughs Wellcome Fund; the March of Dimes; and the Alfred E. Mann Foundation.

Along with Drs. Shenhav and Jauhal, study authors from the Shenhav Lab at NYU Langone Health included Bianca Cordazzo-Vargas, Daniel Sunko, and Pratima Niroula of the Institute for Systems Genetics and Department of Microbiology.

Additional study authors were Lishi Deng, Laeticia Celine Toe (also affiliated with Unité Nutrition et Maladies Métaboliques, Institut de Recherche en Sciences de la Santé in Burkina Faso), Carl Lachat and Trenton Dailey-Chwalibóg in the Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University in Belgium; Ameer Muhammed of the Vaccines and Other Initiatives to Advance Lives (VITAL) Pakistan Trust in Karachi; Aneela Pasha, and Muhammad Imran Nisar in the Department of Paediatrics and Child Health at the Aga Khan University Hospital in Karachi; Yasir Shafiq of the Center of Excellence for Trauma and Emergencies and Community Health Sciences, Aga Khan University; Naveed Iqbal and Waqasuddin Khan  of the CITRIC Center for Bioinformatics and Computational Biology, Department of Paediatrics and Child Health, at Aga Khan; Fyezah Jehan of the Department of Paediatrics and Child Health Medical College, Aga Khan; Andrew Mertens and Alan Hubbard of the Division of Epidemiology, School of Public Health, at University of California Berkeley; Kelsey Fehr and Melissa Manus of the Department of Pediatrics and Child Health, University of Manitoba, Winnipeg, Canada; Joann McDermid, a consultant from Charlottesville, Virginia; Chi-Hung Shu, Megan Beggs, and Nima Aghaeepour of the Department of Anesthesiology, Pain, and Perioperative Medicine at Stanford University School of Medicine; Daniela Hampel and Setareh Shahab-Ferdows of the Institute for Global Nutrition at the University of California Davis; Kim Lagerborg and Mohit Jain of Sapient Bioanalytics in San Diego; Mark DeBoer of the Department of Pediatrics at the University of Virginia School of Medicine; Jennifer Van Eyk of the Smidt Heart Institute, Advanced Clinical Biosystems Research Institute and Barbra Streisand Women's Heart Center, Cedars-Sinai Medical Center in Los Angeles; Natalie Rodriguez of the Office of the Vice-Principal Research and Innovation, University of British Columbia in Vancouver, Canada; Theo Moraes and Padmaja Subbarao of the Translational Medicine Program, Research Institute, at The Hospital for Sick Children in Toronto; Lars Bode in the Department of Pediatrics, Larsson-Rosenquist Foundation Mother-Milk-Infant Center of Research Excellence, Human Milk Institute, University of California San Diego, La Jolla; Lindsay Allen of the Department of Nutrition, University of California Davis; Donna Geddes of the School of Molecular Sciences, The University of Western Australia, Perth, Australia; and Michelle Kay McGuire of the Margaret Ritchie School of Family and Consumer Sciences at the University of Idaho.

About NYU Langone Health
NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient Inc. has ranked NYU Langone No. 1 out of 122 comprehensive academic medical centers across the nation five years in a row, and it continues to have the most No. 1– and top 10–ranked specialties among medical centers in the United States, according to U.S. News & World Report. NYU Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 400 outpatient locations in the New York City area and Florida. The system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise.

---

Journal

Science

DOI

10.1126/science.aee7240

Method of Research

Experimental study

Subject of Research

People

Article Title

Shared Patterns of Human Milk Composition Link Mammary Gland Function to Infant Growth

Article Publication Date

8-Oct-2026

Related News Releases

• Human milk offers a window into mammary gland function—and its links to infant growth
  (NYU Langone Health / NYU Grossman School of Medicine)

First presumptive human case of avian flu acquired in Canada detected in teen

November 09, 2024 

Provincial health officer Dr. Bonnie Henry speaks in Victoria on Thursday, March 10, 2022.

 British Columbia's Ministry of Health says the first suspected human case of bird flu contracted in Canada has been detected in B.C.

 THE CANADIAN PRESS/Chad Hipolito

British Columbia’s Ministry of Health says the first suspected human case of bird flu contracted in Canada has been detected in B.C.

A statement from the office of the provincial health officer says a teenager in the region covered by Fraser Health tested positive for bird flu, and the teen is currently getting treatment at BC Children’s Hospital.

The statement says the positive test was done by the BC Centre for Disease Control, and samples are on their way to Winnipeg’s national microbiology lab for confirmatory testing

It says public health officials are also looking into the case to find the source of exposure and identify any contacts.

Provincial health officer Dr. Bonnie Henry says it is “a rare event” and only a handful of cases of bird flu, caused by the H5N1 strain of the avian influenza virus, have been detected in humans in the U.S. and abroad.

The statement says the source of the teen’s exposure to the virus is very likely to be from an animal or bird, while public health officials and the province’s chief veterinarian investigate.

This report by The Canadian Press was first published Nov. 9, 2024.

Province reports first presumptive positive human case of H5 avian influenza in BC and Canada

BC sees first case of bird flu

Casey Richardson - Nov 9, 2024 / 4:09 pm | Story: 516614

Photo: The Canadian Press

BC announced on Saturday afternoon that an individual in British Columbia had tested presumptive positive for avian influenza, also known as bird flu.

This was the first detection of avian influenza due to the H5 virus in a person in B.C.

The province said this is also the first detection of a presumed human case of H5 avian influenza acquired in Canada.

"The positive test for H5 was performed at the BC Centre for Disease Control's Public-Health Laboratory. Samples are being sent to the National Microbiology Laboratory in Winnipeg for confirmatory testing," the province added.

Currently, the individual, who is a teenager from the Fraser Health region, is receiving care at BC Children's Hospital.

The province said a public health investigation has begun to determine the source of exposure and identify any contacts.

"Our thoughts are with this young person and their family during this difficult time," said Dr. Bonnie Henry, B.C.'s provincial health officer in the news release.

"This is a rare event, and while it is the first detected case of H5 in a person in B.C. or in Canada, there have been a small number of human cases in the U.S. and elsewhere, which is why we are conducting a thorough investigation to fully understand the source of exposure here in B.C."

Anyone who may have been exposed will be contacted by public health to assess for symptoms and provide guidance on testing and prevention measures.

There have been no further cases identified or reported at this time, according to the province.

B.C.'s chief veterinarian and public health teams are also investigating since the source of exposure is believed to be very likely an animal or bird.

The investigation involves public health teams from Fraser Health, BC Centre for Disease Control (BCCDC), the BCCDC Public Health Laboratory, BC Children's Hospital, the Office of the Provincial Health Officer, the Office of the Chief Veterinarian, the Ministry of Agriculture and Food, and others.

"Health, animal and environmental partners across B.C. have also been working together and with the Canadian Food Inspection Agency and other national and U.S. partners to respond to the increased detections of H5N1 avian influenza in poultry farms and wild birds in the province since early October," the province said.

To protect yourself against avian influenza, the following prevention measures are recommended by the province:

• Stay up to date on all immunizations, especially the seasonal flu vaccine.
• Do not touch sick or dead animals or their droppings and do not bring sick wild animals into your home.
• Keep your pets away from sick or dead animals and their feces (poo).
• Report dead or sick birds or animals.
• For poultry or livestock, contact the Canadian Food Inspection Agency (CFIA) Animal Health office: https://inspection.canada.ca/en/about-cfia/contact-cfia-office-telephone#bc-animal(https://https://inspection.canada.ca/en/about-cfia/contact-cfia-office-telephone#bc-animal)
• For pets, contact your veterinarian or call the BC Animal Health Centre at 1 800 661-9903
• For wild birds, contact the BC Wild Bird Mortality Line: 1 866 431-2473
• For wild mammals, contact the BC Wildlife Health Program: 1 250 751-7246

For those who may have been exposed to sick or dead birds or animals or work on a farm where avian influenza has been detected, they are asked to watch for symptoms of influenza-like illness.

Symptoms within 10 days after exposure to sick or dead animals should be reported to a health-care provider, notifying them that you have been in contact with sick animals and are concerned about avian influenza.

"This will help them give you appropriate advice on testing and treatment. Stay home and away from others while you have symptoms."

H5N1 has been detected in wild birds, on poultry farms and among small wild mammals, including skunks and foxes within BC.

The province said most cases have been reported during migration season when wild birds carrying the virus are in high numbers.

"Since the beginning of October 2024, at least 22 infected poultry premises have been identified in B.C., along with numerous wild birds testing positive"

However, there have been no cases reported in dairy cattle and no evidence of avian influenza in samples of milk in BC or Canada.

"Influenza viruses are adaptable and can change when strains from humans or different animal species mix and exchange genetic information. Avian influenza could become more serious if the virus develops the ability to transmit from person to person, with potential for human-to-human transmission" the province said.

More information can be found online here.

Scientists fired from Winnipeg lab over security fears rightly under probe: minister

© Provided by The Canadian Press

OTTAWA — It's "extremely appropriate" that two scientists who lost their jobs due to dealings with China remain under investigation, Health Minister Mark Holland said Wednesday.

The National Microbiology Laboratory researchers were fired in early 2021 after their security clearances were revoked over questions about their loyalty and the potential for coercion by China.

Records tabled in Parliament late last month say the scientists, Xiangguo Qiu and her husband, Keding Cheng, played down their collaborations with Chinese government agencies.

The RCMP said Wednesday a national security investigation into the matter, which begain in May 2019, remains underway.

The Mounties started the probe following a referral from the Public Health Agency of Canada.

The Globe and Mail newspaper reported Wednesday the two scientists have been using pseudonyms as they build a new life in China.

Holland said he was "deeply disturbed" by the scientists' behaviour.

"They're under an investigation, and rightfully so," he said.

"That investigation is ongoing. It would be inappropriate for me to comment on the nature of that investigation. But I would say that it's extremely appropriate that the investigations are occurring."

The documents presented to Parliament show the Canadian Security Intelligence Service concluded that Qiu repeatedly lied about the extent of her work with institutions of the Chinese government.

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8:27

The records also say she refused to admit involvement in various Chinese programs even when evidence was presented to her.

CSIS found that Qiu provided at least two employees of Chinese government institutions access to the microbiology laboratory, and consistently said she had very limited knowledge of these institutions' mandates, "despite an abundance of evidence that she was actually working with or for them."

Upon release of the records, the Public Health Agency said it had taken steps to bolster research security in response to the episode.

The microbiology laboratory has a "renewed, proactive security posture" that has reinforced the physical security of the building, the health agency said.

"Screening measures are strictly enforced for all staff and external visitors, including the requirement for visitors to be accompanied at all times and without exception."

The Public Health Agency needs to provide a fuller explanation of exactly what it has done, said Wesley Wark, a senior fellow with the Centre for International Governance Innovation.

Wark, a national security expert who has closely followed the issue, said the agency must be able to demonstrate concretely how it has changed the lab's practices with regard to security training, data protection and information technology.

"From my perspective, there's two things that we need to know," Wark said.

"One is the details of the changes. The other is, was there a review conducted in order to make those changes, to make sure that they were going to be adequate?"

A spokesman for the Public Health Agency did not have immediate answers Wednesday to questions about the security changes.

This report by The Canadian Press was first published March 20, 2024.

SEE

2 Scientists in Canada Passed On Secrets to China, Investigations Find

New book debunks Winnipeg-lab conspiracy theory but questions collaboration with Chinese military scientist

Feds drop court fight to block documents on firing of National Microbiology Lab scientists

Fired Winnipeg lab scientist listed as co-inventor on two Chinese government patents

Canadian scientist sent deadly viruses to Wuhan lab months before RCMP asked to investigate'

Websites spin unproven link between Canada, China about coronavirus outbreak

Opposition right to be wary of Liberals withholding details about fired Canadian scientists with Wuhan links: expert

Liberal MP questions Justice Department's legal advice on fired scientists

2013 AN EARLIER CASE OF A HONEY POT BUST

THE STRANGE CASE OF THE MISSING TERRORIST SCIENTISTS IN THE NEWS

In April of this year the RCMP announced that they had uncovered a bio-terrorist threat involving two Canadian scientists working for the innocuous sounding: Canadian Food Inspection Agency (CFIA). 

The two CFIA scientists were busted for attempting to sell Brucellis virus to China. In fact one of the scientists, herself Chinese, had gotten away to China.1 They were under investigation for two years when it became known that they were trying to commercialize the bacteria they had developed with CFIA.

2 Scientists in Canada Passed On Secrets to China, Investigations Find

After a prolonged Parliamentary debate, details about two microbiology researchers who were found to have shared secrets with China have been released.

The couple were escorted from their labs at the National Microbiology Laboratory in Winnipeg, Manitoba, in 2019 and later stripped of their security clearances. They were fired in January 2021.

Credit...John Woods/The Canadian Press, via Associated Press


By Ian Austen
Reporting from Ottawa
Feb. 29, 2024,

Two scientists who worked at Canada’s top microbiology lab passed on secret scientific information to China, and one of them was a “realistic and credible threat to Canada’s economic security,” documents from the national intelligence agency and a security investigation show.

The hundreds of pages of reports about the two researchers, Xiangguo Qiu and Keding Cheng, who were married and born in China, were released to the House of Commons late Wednesday after a national security review by a special parliamentary committee and a panel of three retired senior judges.

Canadian officials, who have warned that the country’s academic and research institutions are a target of Chinese intelligence campaigns, have tightened rules around collaborating with foreign universities. Canadian universities can now be disqualified from federal funding if they enter into partnerships with any of 100 institutions in China, Russia and Iran.

The release of the documents was the subject of a prolonged debate in Parliament that began before the last federal election, in September 2021. Opposition parties asked to see the records at least four times and found the Liberal government to be in contempt of Parliament in 2021. The government filed a lawsuit in an attempt to keep the records hidden, but dropped it when the vote was called.

The release comes as the country is holding a special inquiry led by a judge to look into allegations that China and other foreign nations have interfered in Canadian elections and political parties. Some of Prime Minister Justin Trudeau’s political opponents have charged that his government has failed to respond adequately to Chinese meddling in Canadian affairs.

But Mark Holland, the federal health minister in Canada, told reporters late Wednesday that at “no time did national secrets or information that threatened the security of Canada leave the lab.”

The couple were escorted out of their labs at the National Microbiology Laboratory in Winnipeg, Manitoba, during the summer of 2019 and later stripped of their security clearances. They were fired in January 2021.

More on China China’s Hacker Network: Leaked documents recently posted online show how the Chinese government is working with private hackers to obtain sensitive information from foreign governments and companies.

Fed-Up Investors: It’s a perilous time for investors in China. As their losses pile up, they are losing confidence not only in the stock market but in the government’s ability to turn the economy around.

Seeking a Friendlier Image: Faced with declining foreign investment at home, China has sought to soften its image abroad. Liu Jianchao, a Communist Party official, has played an unusually prominent role in the shift in tone.

‘Shawshank’ on Stage: A stage adaptation of the film “The Shawshank Redemption” in Beijing, cast with Western actors speaking fluent Mandarin Chinese, has raised questions about translation, both linguistic and cultural.

The same year, the government released heavily redacted records about their dismissal, setting off a battle with opposition parties that were demanding more detail about the security breach.

The large cache of newly released documents, which have significantly fewer redactions, offer more details about the scientists’ unauthorized cooperation and information exchanges with Chinese institutions. The documents also revealed that Dr. Qui had not disclosed formal agreements with Chinese agencies in which a Chinese institution agreed to pay substantial amounts of research money. It also agreed to pay her an annual salary of 210,000 Canadian dollars (about $155,000).

The couple could not be located, and they did not appear to have any obvious local representatives. Some Canadian news outlets have reported, based on undisclosed sources, that they moved to China after being dismissed. The Royal Canadian Mounted Police opened a criminal investigation in 2021, but its status is unclear and no charges have been laid.

The documents released on Wednesday do not include any general response from the couple. But they show that during questioning by investigators, Dr. Qui repeatedly said that she was not aware that she had broken any security rules, blamed the health agency for not fully explaining procedures and frequently tried to mislead investigators until confronted by contradictory evidence.

In a letter to Dr. Qui, the public health agency said that she “did not express remorse or regret. You failed to accept responsibility for your actions and deflected blame onto P.H.A.C.” It added that she did not show “any signs of corrective behavior, rehabilitation or desire for resolution of the situation.”

The Canadian Security Intelligence Service also found that Dr. Qiu repeatedly misrepresented her ties to researchers and organizations in China, relationships it characterized as “close and clandestine.”

In one secret report, the intelligence agency said that when she was asked about her exchanges with scientists and organizations in China, she “continued to make blanket denials, feign ignorance or tell outright lies.”

An internal investigation report for the Public Health Agency of Canada, which includes the lab, shows that the couple fell under suspicion in 2018, when Dr. Qiu was named an inventor on a patent granted in China that appeared to use research developed by the agency for an Ebola vaccine.

That revelation, in turn, suggested that the couple had engaged in several violations of security rules at the laboratory, portions of which are designed for work on the world’s most lethal microbes, including ones that could be used for biological warfare.

Those breaches included attempts by graduate students of Dr. Qiu at the University of Manitoba, all of whom were Chinese nationals, to remove material from the lab and being allowed to wander through the facility unescorted.

In one episode, X-rays revealed that a parcel delivered to the lab for Dr. Cheng — and labeled “kitchen utensils” — contained vials of mouse proteins. The discovery underscored that Dr. Cheng had broken protocols, according to the documents.

An investigation by the intelligence agency found that Dr. Qiu had a formal agreement with Heibei Medical University to work on a “talent program,” something it described as a project “to boost China’s national technological capabilities.”

A report documenting the investigation added that it “may pose a serious threat to research institutions, including government research facilities, by incentivizing economic espionage.” That agreement promised about 1.2 million Canadian dollars (roughly $884,000) in research funding. The agency said the couple did not disclose, as required, that they maintained a bank account in China.

Dr. Qiu, the intelligence service said, also had a résumé she used only in China that showed she was a visiting professor at three Chinese health research institutes and a visiting researcher at a fourth one.

Exactly what information Dr. Qiu may have provided to China and how China may have used it is not clear either from the internal investigation or the intelligence agency reports.

The intelligence service said that many of the institutions she worked with researched “potentially lethal military applications.” When asked as part of an internal investigation about the potential military uses of her work, Dr. Qiu said that the idea had not occurred to her, the documents show.

The internal investigation found that a trip Dr. Qiu made to Beijing in 2018 was paid for by a Chinese biotechnology company.

Mr. Holland said that the lab’s management had demonstrated an “inadequate understanding of the threat of foreign interference.”

He added, “I believe that an earnest effort was made to adhere to those policies, but not with the rigor that was required.”

In a statement, Pierre Poilievre, the Conservative leader, said that the Chinese government and its agencies, “including the People’s Liberation Army, were allowed to infiltrate Canada’s top-level lab.” The statement added, using the abbreviation for the People’s Republic of China, “They were able to transfer sensitive intellectual property and dangerous pathogens to the P.R.C.”

Vjosa Isai contributed reporting from Toronto.

Ian Austen reports on Canada for The Times based in Ottawa. He covers politics, culture and the people of Canada and has reported on the country for two decades. He can be reached at austen@nytimes.com. More about Ian Austen

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

By Patti Sonntag Global News
Posted January 11, 2024 

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, 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.

In a statement issued after this article was published on Jan. 11, 2024, the Prime Minister’s Office wrote that BTNX’s antigen “rapid tests work well and have been successfully used by millions of Canadians” to fight COVID-19. A spokeswoman described Health Canada’s decision-making as “independent.”

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 for the nasal test 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.

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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 also 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.

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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.