Health regulators in five countries are investigating non-invasive prenatal test NIFTY, over data protection concerns.
Concerns were raised when Reuters claimed in July that NIFTY, marketed by Chinese company BGI Group, was developed in conjunction with the military (see BioNews 1103). Although Reuters found no evidence of data protection breaches by BGI Group, regulators are calling for greater transparency over their research purposes.
Regulators in Germany, Slovenia, Estonia, Canada, and Australia are examining the test, citing that local vendors are responsible for data protection even if samples are sent abroad.
'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.
The Ontario regulator has since advised women to seek prenatal tests from Canadian providers, to ensure 'comparable' data security. Elsewhere, in Germany regulators have suspended transfer of patient data to BGI Group from Eluthia GmBH, a laboratory that sells NIFTY.
The NIFTY test, currently marketed in at least 52 countries, detects genetic abnormalities in fetuses by examining fetal DNA in the mother's blood. Patients are asked for consent for their data to be used for unspecified research purposes, such as in Hong Kong where data may be stored for five years. The consent form also specifies that data may be shared with Chinese authorities in matters of national security, though BGI Group claims it has never been asked to do so.
In its report published in July, Reuters asserted that NIFTY data were used for research such as preventing altitude sickness in Chinese soldiers, and a mass pathogen testing programme. Although BGI Group has stressed that its research only uses anonymised data, regulators are concerned that the nature of the research is not transparent.
'It is vital that the patient is provided with clear information,' said Dr Beverley Rowbotham, chair of Australia's National Pathology Accreditation Advisory Council.
BGI Group maintains that although it collaborates with military hospitals, the NIFTY test was not developed with the Chinese military. BGI Group has confirmed to Reuters that it is providing information to regulatory authorities to demonstrate its compliance with data protection laws.