September 6 (Reuters) – Health regulators in five countries are examining prenatal test that collects DNA from women and fetuses for research, while some doctors who have promoted it and clinics selling it say that they were unaware that the company that produces it is also conducting research with the Chinese military.
The test, carried out by the Shenzhen-based BGI group and marketed under the NIFTY brand, is sold in at least 52 countries. It screens for Down syndrome and over 80 other genetic diseases, and has been used by 8.4 million women worldwide.
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 was addressing the issue. Two European regulators – in Slovenia and Germany – have said they are reviewing 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 about exporting data from BGI tests and would look into data protection issues. But he added that Slovenia has not yet adopted changes to its national laws to make the European General Data Protection Regulation (GDPR) fully applicable, so that it cannot impose fines in GDPR violation.
Reuters reported in July that more than a dozen scientific studies – including clinical trials – showed that BGI had developed and improved the test in collaboration with People’s Liberation Army hospitals. BGI uses genetic data from pregnant women for population trait research. 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. He said he works with thousands of health care providers, other prenatal testing providers in China work with military hospitals, and many companies around the world work with the military. He said he takes data privacy seriously, complies with applicable laws and regulations, and that only 5% of his NIFTY tests have been performed on women overseas.
Regulators in Germany, Australia, Estonia and Canada have called for transparency in BGI’s use of women’s genetic data, and said that even though the data is sent overseas, BGI’s local providers are responsible for ensuring the confidentiality of data. The European Data Protection Supervisor said he was monitoring the situation.
“It is essential that the patient receives clear information,” said Beverley Rowbotham, chair of the National Pathology Accreditation Advisory Council of Australia.
An Ontario regulator told Reuters it is now advising women to seek testing from vendors in Canada, or in places where data security is “comparable” to protections mandated in Canada. Quebec’s regulatory body has said prenatal testing – like consumer genetic testing – can lead to loss of control over their genetic information. Canadian privacy and genetic disclosure laws can impose fines of up to C $ 250,000 to C $ 1 million for violations and establish strict conditions for exemptions for scientific research.
“DNA information is not only valuable for traders and data brokers, but also for foreign states and cybercriminals,” the Information and Privacy Commission Office told Reuters. Ontario.
Fertility Partners, a network of clinics in Canada, said it had no prior knowledge of BGI’s work with the APL and stopped selling NIFTY through its clinics in April for unrelated reasons.
Reuters 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 genomic database that BGI is amassing and analyzing with artificial intelligence could give China a path to economic and military advantage. Read more
The same military hospital that conducted clinical trials for NIFTY also worked with BGI to send pathogens into space as part of a military equipment research program, according to 12 scientific papers, which did not previously reported. BGI did not respond to a request for additional information on this research program.
In the UK, where NIFTY tests are only sold in private clinics, the government said BGI would have to register its test by September 1 to continue selling them. BGI told Reuters it submitted a voluntary registration to the UK medical regulator in August. The UK Medicines and Health Products Regulatory Agency (MHRA) told Reuters it had received registration from BGI, but said the request had not yet been validated and a review of the data by the regulator’s recording and software team. Read more
NIFTY tests are sold overseas through three business models: local clinics collect blood samples to send to BGI in Hong Kong; the laboratories sequence the DNA of blood samples locally and share the data with BGI in Hong Kong where it is stored for five years; where laboratories complete the entire process locally using BGI technology.
Laboratories in Spain and Slovenia each told Reuters that a client’s genetic data had been used by BGI in mainland China for research purposes, with informed consent.
Slovenia-based GenePlanet, which says it sells the NIFTY tests across Europe and also offers its own test using BGI technology, said the Slovenian customer had agreed to a “research test”.
GenePlanet says it operates under EU regulations and has an agreement with BGI that “none of the GenePlanet patient data generated by (the) NIFTY process will go to mainland China.”
Data on Slovenian and Spanish women were among those for 542 women stored in China’s national bank of GeneBank, which BGI also manages. BGI said the data from the 542 women had not been used for other purposes and that its “scientific research only uses anonymized data.”
Eluthia GmbH, a German laboratory that sells BGI’s test, said its transfer of female blood and patient data to BGI has been suspended by the Hessian region data protection regulator while it investigates to find out if the rules had been violated read more.
Eluthia said she did not know when she could resume sending tests to BGI. Its chief executive, Ramon Enriquez Schaefer, said doctors called the suspension “excessive” since patients “expressly consented to the shipment to Hong Kong.” He also said Eluthia had not been able to make “concrete progress” on the regulator’s concerns about BGI’s military collaboration.
BGI told Reuters it was providing information to Eluthia and relevant government authorities to demonstrate that it complies with data protection laws.
DOCTORS ‘POINTS OF VIEW
A British doctor who promoted the BGI 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 anyone not to use the BGI NIFTY test – not from a clinical point of view – but because the resulting data could be misappropriated or used for reasons that neither the clinician nor the patient would ever have imagined, ”said Bryan Beattie, consultant in fetal medicine.
Reuters contacted Beattie and two other British doctors who also promoted the test on BGI’s YouTube channels in 2014 for their feedback. Medics said they were not aware of BGI’s military ties. BGI said doctors were not paid to participate and told them the videos were for educational and marketing purposes.
The NIFTY test captures more genetic information about the mother and fetus than the results patients see, said Beattie, which has previously been reported by Reuters and BGI has confirmed.
“If you could relate that to a lot of patients in a foreign country, you would have a pretty good idea of their health profile over the next 20 or 30 years,” Beattie said.
Beattie said he had supported the relatively new technology because it was an improvement over previous methods, but his clinic had switched to another provider 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 that European health services, which he declined to name, would choose the BGI test because of its lower cost and do not take into account data security. .
“It’s a stupidly easy way to make money taking a blood sample,” said Kaarel Krjutskov, who heads the Estonian lab.
BGI has refused to sell its lab a DNA sequencer unless it also starts selling NIFTY, an email correspondence seen by Reuters showed.
BGI’s marketing material promotes its gene sequencing as the lowest cost in the industry. BGI told Reuters it “is always working to make our NIFTY fares even more affordable”, without providing further details.
Reporting by Clare Baldwin in Hong Kong and Kirsty Needham in Sydney 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 Edited by Sara Ledwith, Kevin Krolicki and Bill Rigby
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