Articles In The News — 16 July 2014

The Chinese Food and Drug Administration have just opened a huge new market for a revolutionary, essentially risk-free prenatal test for the three most common genetic diseases. The NIFTY test, designed by the Beijing Genomics Institute, is a simple, highly accurate, and non-invasive test that is now available to millions of Chinese women.

 The NIFTY test requires a mere 10ml of a mother’s blood, bringing the risk to the mother and child down to almost zero.

 

Genetic abnormalities are among the greatest fear that a pregnant woman might have when expecting a child, especially those over the age of 30. Trisomy 21 (Down’s syndrome), 18 (Edwards syndrome), and 13 (Patau syndrome) all result from genetic abnormalities, but the tests for these diseases can often be dangerous. Women with preexisting conditions such as the placenta previa, the tendency to miscarry, and HIV are especially at risk, particularly during later-life pregnancies. Classical tests for this condition requires drawing fluid from the amniotic sac, which can stress both the mother and child, leading to intrauterine infection and the potential for abortion. Other non-invasive tests are often much less accurate. They lead to false negatives and, arguably worse, false positives.

 

The NIFTY test requires a mere 10ml of a mother’s blood, bringing the risk to the mother and child down to almost zero. Unlike most other tests which are much more time sensitive, NIFTY is available anytime between the 10th and 24th week of gestation. It provides a 99.9% accuracy with a negligible 0.1% possibility of a false positive.

 

While still reasonably expensive (£370-£490 in London), one might expect the cost to come down now that the market for this technology has been blown open by the addition of Chinese clients. China is very keen to ride the wave of genetic research, specifically in synthetic biology. In 2011 it allocated significant money to support four science research programs focusing on synthetic biology  .  The registrations of BGI’s sequencers BGISEQ-1000, BGISEQ-100 and its diagnostic kits for fetal chromosomal aneuploidy emphasizes China and BGI’s commitment to approaching the forefront of genomic research, development, and industry.

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Dan Lipworth

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