Berry Genomic’s “Non-invasive” Down Syndrome Prenatal test Illegal in China?

China’s most recent “2013 Clinical Testing Standards Manual”《医疗机构临床实验室管理办法》 covering clinical hospital tests neglects to mention the popular noninvasive prenatal test diagnosing Down Syndrome babies in pregnant women, made by Berry Genomics,贝瑞和康.

Does this mean it is illegal? Deputy Wang Liang Gang of Beijing Law Association’s Medical Committee seems to think so. “If it’s not mentioned, it’s not legal.”

Berry Genomics, which has successfully carved a market for itself by licensing a technology which allows it to collect and enrich fetal DNA from the mother’s blood, has created a diagnostic tool (Bambni) to test for Trisomy 21, an extra copy of chromosome 21 which leads to Down Syndrome, exemplified by mental retardation as well as other physical ailments. The technique is relatively non-invasive and acquires cell-free fetal DNA, which is then analyzed to confirm the presence or absence of a third copy of chromosome 21. The alternative used to be using a large needle that penetrates the mother’s abdomen to collect samples. The new technique is relatively safer and also accurate. It has already been used around 50,000 times in hospitals in China, typically resulting in aborted fetuses if the condition, which is purportedly 99% accurate, is confirmed.

The recent regulatory change may put a damper on this increasingly popular test.


3 Responses to “Berry Genomic’s “Non-invasive” Down Syndrome Prenatal test Illegal in China?”

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