3 July 2014
China has issued the first regulatory approval for a non-invasive prenatal genetic testing product – to the Chinese Bejing Genomics Institute (BGI).
The China Food and Drug Administration (CFDA) has approved the registration of DNA sequencers BGISEQ-1000 and BGISEQ-100 from the Bejing Genomic Institute (BGI) for clinical applications. It has also approved BGI’s non-invasive prenatal testing (NIPT), dubbed ‘second-generation gene sequencing diagnostic products’ for use in pregnant women at high risk of having fetuses with common chromosomal abnormalities (trisomies 21, 18 and 13).
Barriers to uptake of testing
Peking University People’s Hospital Director of Obstetrics Zhang Xiaohong told the South China Morning Post that implementation of the technologies would not be simple, requiring official permission to purchase the testing equipment, train technicians and establish a service. Moreover, the test price of 2,500 yuan (HK$3,100) per patient was said to be around half the average monthly household income.
Demand for NIPT by high-risk women in Hong Kong has previously been shown to be high, but the cost barrier could prove more significant for average income households in mainland China. However, since most families still have only one child, it could come to be considered an essential investment for those at high risk of having an affected child.
Implications for BGI and foreign competitors
The BGI non-invasive prenatal tests are the first to be approved since the CFDA suspended all medical genetic testing in China earlier this year. The CFDA now says it will work to strengthen the supervision of genetic testing and allow the general public more access to innovative medical products.
How far the Chinese market will be accessible to foreign providers of NIPT and other genetic testing products remains to be seen. For the time being, the BGI has complete monopoly on the internal market. Possibly in anticipation of this move, subsidiary company BGI Shenzhen, which specialises in NIPT, last month raised US$320 million in investments from ‘several unnamed Chinese institutional investors’, who acquired a 20% stake in the company.