China approves DNA-sequencing devices to detect genetic defects in unborn babies

Controversial testing products for prenatal detection of birth defects get the green light

PUBLISHED : Thursday, 03 July, 2014, 4:56pm
UPDATED : Friday, 04 July, 2014, 5:35pm

The mainland has lifted the controversial ban on medical diagnostic products that can help detect birth defects in unborn children.

The China Food and Drug Administration (CFDA) on Monday approved the registration of genomics company BGI's sequencers - which help map out the sequence of a person's genetic code, which in turn determine traits such as eye colour and skin colour or even the propensity to certain diseases.

The medical devices, called second-generation gene sequencing diagnostic products, are used for non-invasive tests on the foetus to detect genetic diseases such as Down's syndrome.

The CFDA also approved diagnostic kits for "high-risk" pregnant women, such as those older than 35.

Such diagnostic products were introduced in China in 2011, initially for prenatal testing, but later extended to early detection of cancer and other diseases.

But last February, the government banned all medical applications of "gene-sequencing technology products", claiming that some medical institutes were charging extortionate fees, and that it was too difficult to regulate the quality of the services.

Some mainland media speculated at the time that authorities were also worried that the new technology could be used to determine the sex of foetuses even though public hospitals are prohibited from revealing such information after fetal screenings or ultrasound.

Sex testing is banned on the mainland, which has one of the world's highest gender imbalances - about 119 boys are born for 100 girls. This has been attributed to a traditional preference for boys and the high number of abortions resulting from the one-child policy.

The ban sparked controversy on the mainland and such screening went underground because of the genuine demand for many pregnant women for early detection of genetic diseases, according to a report in May by Health News, published by the National Health and Family Planning Commission.

Mainland media and medical professionals have called for the lifting of the ban since February.

Zhang Dan, a doctor at Zhejiang University, told news portal in March the government should prohibit the use of the products for sex testing instead of imposing a blanket ban.

But Zhang Xiaohong , director of obstetrics at Peking University People's Hospital, told the newspaper it would not be simple to roll out the technology.

Zhang said hospitals must obtain the family planning commission's permission to buy the equipment, then establish non-invasive genetic testing procedures and train technicians.