Prenatal gene test Nifty under international scrutiny amid links to Chinese military
Health regulators in five countries are examining a prenatal test that collects the DNA of women and foetuses for research after it emerged the test’s manufacturer has links to China’s military.
Some doctors and clinics that promoted and sold the test, marketed under the brand name Nifty, said they were unaware that Shenzhen-based BGI Group also conducts research with the Chinese military.
The test is sold in at least 52 countries and has been taken by 8.4 million women globally. It screens for Down’s syndrome and more than 80 other genetic conditions.
Canada’s privacy commissioner said a Reuters report on the issue raised important questions about “highly sensitive” information. The commission 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.
Regulators in Germany, Australia, Estonia and Canada called for transparency in BGI’s use of women’s genetic data, and said that even if data was sent abroad, BGI’s local vendors were 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.
The regulators’ concerns highlight the challenges of regulatory oversight when genetic data is sent from one country to another.
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.
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 (PLA) 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 rejected any suggestion that it developed the Nifty test in collaboration with the military, and said working with military hospitals was not equivalent. It said it worked 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 took data privacy seriously, complied with applicable laws and regulations, and that only 5% of its Nifty tests had been conducted on women overseas.
Reuters found no evidence BGI violated privacy agreements or regulations; the company said it obtains signed consent and destroys overseas samples and data after five years. “At no stage throughout the testing or research process does BGI have access to any identifiable personal data,” the company said.
Consent forms signed by women outside China seek permission for their blood samples and genetic data to be sent abroad to BGI and used for research. The privacy policy on the test’s website also says data can be shared for national security purposes in China – though BGI says it has never been asked to do so.
A regulator in Ontario told Reuters it was now advising women to seek tests from providers in Canada, or places where data security is “comparable”. 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$1m for breaches, and set strict conditions for exemptions for scientific research.
“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 said.
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. US government advisers warned in March that a vast bank of genomic data that BGI is amassing and analysing with artificial intelligence could give China a path to economic and military advantage.
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 “research test”.
GenePlanet said it operated according to EU regulations and had an agreement with BGI that “none of the GenePlanet patient data generated from [the] Nifty process is going to mainland China”.
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 data”.
Eluthia GmbH, a laboratory in Germany that 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 violated.
BGI told Reuters it was providing information to Eluthia and relevant government authorities to demonstrate it complies with data protection laws.