Product News: Launch of New Non-Invasive Screening Test Which Can Reduce Risk of Miscarriage

09 Oct 2013

BGI Health is marking Baby Loss Awareness Week (9-15 October) with the launch of a new non-invasive screening test for Down’s Syndrome and other conditions, which can reduce the risk of miscarriage significantly compared with other, potentially unnecessary invasive procedures.

BGI Health is hoping to reduce a significant number of miscarriages through the introduction of its NIFTY screening test. This test is the most validated on the market - as proven by a published clinical study involving more than 11,000 pregnant women, which showed that using the new, highly accurate, yet simple blood test prevented up to 110 potential miscarriages.

Currently, all mothers-to-be are offered the opportunity to take part in the NHS screening programme to detect Down’s Syndrome. Mothers are given the combined test – a blood test which checks for hormone levels in the mother’s blood, and a scan at 12 weeks which measures fluid on the back of the baby’s neck – the nuchal fold test. However, these screening test results can only tell mothers whether they are at low or high risk of having a baby with Down’s Syndrome.

Mothers with a high risk result are sent for an invasive diagnostic procedure – such as an amniocentesis - which carries a miscarriage risk. This does confirm whether the baby has Down’s Syndrome or not.

However, the current screening tests have around a 5% false positive rate – this means that 5% of the women who receive a high risk result, actually have perfectly healthy babies, and are being sent for the invasive tests when they don’t need them.

The new highly accurate NIFTY test from BGI Health, could prevent those 5% of women from undergoing the invasive procedure, saving them from the risk of miscarriage.

The clinical study, published in Prenatal Diagnosis Journal last year, showed that using the test prevented up to 111 potential miscarriages among the high risk women. The test was also proven to have a 99.9% accuracy rate for detecting Trisomy 21 – which causes Down’s Syndrome.

NIFTY works with a simple blood test from the mother. The test detects free floating foetal DNA in the mother’s blood, using next generation sequencing technology, coupled with advanced bioinformatics analysis, giving a much more accurate picture.

Mothers who go through the routine screening programme, and receive a high risk result, could then undertake the NIFTY test to get a more accurate result, without any risk of miscarriage. It can be performed from 10 weeks onwards and used for any women, even those who have undergone IVF or egg donation.

Ning Li, Chief Executive of BGI Health, said: “Our NIFTY test is the most clinically validated test on the market and has been proven to be fast, reliable and most importantly, highly accurate. It has the potential to save many women the agonizing decision of whether to take the risk of going through a potentially unnecessary invasive procedure, providing peace of mind and reducing the chances of miscarriage.”

Almost 180,000 NIFTY tests have been performed across Europe and worldwide and it is now newly available for mums-to-be in the UK.

For more information, please visit the NIFTY website by clicking the company website link below, or click on the ‘request information’ tab beneath the article to email the Sales Director.