Sept 6 (Reuters) - Health regulators in five countries are
examining a prenatal test that collects the DNA of women and
fetuses for research, while some doctors that promoted it and
clinics that sell it say they were unaware the company that
produces it also conducts research with the Chinese military.
The test, made by Shenzhen-based BGI Group and marketed
under the brand name NIFTY, is sold in at least 52 countries. It
screens for Down syndrome and more than 80 other genetic
conditions, and has been taken by 8.4 million women globally.
The regulators' concerns, raised in response to a Reuters
report, highlight the challenges of regulatory oversight when
genetic data is sent from one country to another. Canada's
privacy commissioner said the report raised important questions
about "highly sensitive" information and it is looking into the
matter. Two regulators in Europe - in Slovenia and in Germany -
said they were examining the test in light of European Union
data protection rules.
The data privacy regulator in Slovenia, where one of BGI's
regional partners is based, said it was concerned by the
exporting of data from the BGI tests and would examine data
protection issues. But it added that Slovenia has not yet
adopted the changes to its national laws to make Europes
General Data Protection Regulation (GDPR) fully applicable, so
it cannot issue fines in the event of GDPR breaches.
Reuters reported in July that more than a dozen scientific
studies - including clinical trials - showed BGI developed and
improved the test in collaboration with People's Liberation Army
hospitals. BGI uses the pregnant women's genetic data for
research into the traits of populations. It also collaborates
with the PLA in other areas of research.
BGI rejects any suggestion that it developed the NIFTY test
in collaboration with the military, and says working with
military hospitals is not equivalent. It said it works with
thousands of healthcare providers, that other prenatal test
providers in China work with military hospitals, and that many
companies worldwide work with militaries. It said it takes data
privacy seriously, complies with applicable laws and
regulations, and only 5% of its NIFTY tests have been conducted
on women overseas.
Consent forms signed by women outside China seek permission
for their blood samples and genetic data to be sent abroad to
website also says data can be shared for national security
purposes in China - though BGI says it has never been asked to
Regulators in Germany, Australia, Estonia and Canada called
for transparency in BGI's use of women's genetic data, and said
even if data was sent abroad, BGI's local vendors are
responsible for ensuring data privacy. The European Data
Protection Supervisor said it was monitoring the situation.
"It is vital that the patient is provided with clear
information," said Beverley Rowbotham, chairperson of
Australia's National Pathology Accreditation Advisory Council.
A regulator in Ontario told Reuters it is now advising women
to seek tests from providers in Canada, or places where data
security is "comparable" to the protections mandated in Canada.
The regulator in Quebec said prenatal tests - like consumer
genetic tests - can result in people losing control over their
genetic information. Canadian privacy and genetic disclosure
laws can impose maximum fines of C$250,000 to C$1 million for
breaches, and set strict conditions for exemptions for
"Genetic information is not only valuable to marketers and
data brokers, but also to foreign states and cybercriminals as
well," the Office of the Information and Privacy Commission of
Ontario told Reuters.
Fertility Partners, a clinic network in Canada, said it had
no prior knowledge of BGI's work with the PLA, and had stopped
selling NIFTY through its clinics in April for unrelated
Reuters has previously reported that BGI's joint research
with PLA medical institutes is wide ranging, from efforts to
protect soldiers from altitude sickness to mass testing for
pathogens. U.S. government advisers warned in March that a vast
bank of genomic data that BGI is amassing and analyzing with
artificial intelligence could give China a path to economic and
The same military hospital that ran clinical trials for
NIFTY also collaborated with BGI to send pathogens into space
under a military equipment research program, according to 12
scientific papers, which has not previously been reported. BGI
did not respond to a request for more information about that
In the United Kingdom, where NIFTY tests are only sold
through private clinics, the government said BGI would need to
register its test before Sept. 1 to continue selling them. BGI
told Reuters it submitted a voluntary registration to the UK
medical regulator in August. The UK Medicines and Healthcare
products Regulatory Agency (MHRA) told Reuters it had received
BGIs registration but said the application had not yet had data
validation and scrutiny by the regulator's registration and
NIFTY tests are sold overseas through three business models:
local clinics collect blood samples to send to BGI in Hong Kong;
labs sequence the DNA from blood samples locally and share the
data with BGI in Hong Kong where it is stored for five years; or
labs complete the entire process locally using BGI technology.
Labs in Spain and Slovenia each told Reuters the genetic
data of a client had been used by BGI in mainland China for
research, with informed consent.
Slovenia-based GenePlanet, which says it sells NIFTY tests
across Europe and also offers its own-branded test using BGI's
technology, said the Slovenia customer gave consent for a
GenePlanet says it operates according to EU regulations and
has an agreement with BGI that "none of the GenePlanet patient
data generated from (the) NIFTY process is going to mainland
The Slovenian and Spanish women's data was among that of 542
women stored in China's National GeneBank, which BGI also runs.
BGI said the data of the 542 women has not been used for other
purposes, and its "scientific research only uses anonymised
Eluthia GmbH, a laboratory in Germany which sells BGI's
test, said its transfer of women's blood and patient data to BGI
had been suspended by the data protection regulator for the
Hesse region while it investigates whether the rules had been
Eluthia said it did not know when it could resume sending
tests to BGI. Its Chief Executive Ramon Enriquez Schaefer said
doctors had called the suspension "excessive" since patients had
"expressly consented to the shipment to Hong Kong." He also said
Eluthia hasn't been able to make "concrete progress" on the
regulator's concerns about BGI's military collaboration.
BGI told Reuters it is providing information to Eluthia and
relevant government authorities to demonstrate it complies with
data protection laws.
One UK doctor who promoted BGI's test in an online video
when it first became available said he would now advise women
not to take the BGI test, due to privacy concerns.
"My personal view now would be to advise anybody not to use
the BGI NIFTY test - not from a clinical point of view - but
because the data from it might be misappropriated or used for
reasons that neither the clinician nor the patient would ever
have imagined," said Bryan Beattie, a fetal medicine consultant.
Reuters contacted Beattie and two other UK doctors who also
promoted the test on BGI's YouTube channels in 2014 for their
reactions. The doctors said they were unaware of BGI's military
links. BGI said the doctors were not paid to participate and it
had told them the videos were for educational and marketing
The NIFTY test captures more genetic information about the
mother and the fetus than the results patients see, said
Beattie, which has previously been reported by Reuters and BGI
"If you were able to link that to large numbers of patients
in a foreign country, you would have a fairly good idea of their
health profile over the next sort of 20 or 30 years," said
Beattie said he had supported the relatively new technology
because it was an improvement on previous methods, but his
clinic had switched to a different supplier for reasons
unrelated to privacy.
An Estonian scientist who turned down an offer from BGI in
2020 to replace a test developed by his lab with NIFTY said he
was concerned European health services, whom he declined to
name, were choosing BGI's test because of its cheaper cost and
not considering data security.
"It is a stupidly easy way to earn money for taking a blood
sample," said Kaarel Krjutskov, who runs the Estonian lab.
BGI declined to sell his lab a DNA sequencer unless it also
began selling NIFTY, email correspondence seen by Reuters
BGI's marketing material promotes its sequencing of genes as
the lowest cost in the industry. BGI told Reuters it was "always
striving to make our NIFTY pricing even more affordable,"
without providing further details.
(Reporting by Clare Baldwin in Hong Kong and Kirsty Needham in
Additional reporting by Allison Martell in Toronto, Allison
Lampert in Montreal, Douglas Busvine in Berlin, Tarmo Virki in
Tallinn, Alistair Smout and Tom Bergin in London, Krisztina Than
in Budapest, Robert Muller and Jan Lopatka in Prague, Radu
Marinas in Bucharest, Nathan Allen in Madrid, Joanna Plucinska
and Alicja Ptak in Warsaw, Ludwig Berger in Frankfurt, Foo Yun
Chee in Brussels, Michael Martina in Washington and Antoni
Slodkowski in Tokyo
Editing by Sara Ledwith, Kevin Krolicki and Bill Rigby)