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China lifts ban on prenatal genetic testing

This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

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.

Read the full, original story: China approves DNA-sequencing devices to detect genetic defects in unborn babies

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