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Non-invasive prenatal test

Non-invasive prenatal test (NIPT) – Genesis Serenity

Introduction

The Genesis Serenity® test is a non-invasive prenatal test (NIPT) that offers the reassurance of knowing in the early stages of pregnancy, as early as
10 weeks, that your baby is at low risk of Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), and Patau Syndrome (Trisomy 13).
Other tests that are commonly requested are sex chromosome linked conditions such as Klinefelter syndrome and Turner syndrome. (Please speak to your consultant for further details on this) The test does not assess risk for mosaicism, partial trisomies or translocations.
The test will provide accurate answers when they matter most — simply, safely, sooner.

How is it performed?

Your baby’s cell free DNA can be detected circulating in your blood and so it requires a simple blood test, which is sent to the lab, analysed and the results returned within one week. The test uses DNA sequencing to count the number of copies of all chromosomes, and then uses a calculation method to determine if there are too many or too few copies of chromosomes 13,18, 21, X, Y present in your fetus.

You will also be required to have an ultrasound scan prior to the blood test to check the viability of your pregnancy.

Who can have it?

It can be carried out for most pregnancies including IVF, singleton and twins. It can be performed on women who have conceived via assisted reproductive technology (ART) including use of a donor egg.

Is the test conclusive?

Although the test is not 100% conclusive*, it is highly accurate.

The test identifies, in singleton pregnancies: more than 99% of fetuses with Trisomy 21; 98% of fetuses with Trisomy 18; 98% of fetuses with Trisomy 13; and 95% of fetuses with Turner Syndrome. X and Y analysis provides >99% accuracy for fetal sex. Accuracy for detecting other sex chromosome anomalies varies by condition.

The risk of requiring further testing such as CVS or Amniocentesis after an NIPT test is dramatically reduced.

How does this test differ from other prenatal tests?

The NIPT test is able to deliver a much higher accuracy than other prenatal tests, such as Nuchal translucency or quadruple blood tests), giving you greater peace of mind. It’s totally non-invasive, posing minimal risk to mother or baby, can test for more than just Down Syndrome, and can be carried out as early as 10 weeks’ pregnant.
NHS Down Syndrome screening tests are typically undertaken via a nuchal translucency ultrasound between 11 and 14 weeks. This can only estimate the risk of your baby having Down’s, it can’t tell you for sure either way. For example, if your result is one in 1,000, this means that for every 1,000 babies with your level of risk, one will have Down’s syndrome. A risk of one in 150 or less is considered high. If for some reason the scan cannot be completed, expectant mothers
are offered a blood test between 14 and 20 weeks of pregnancy, which is less accurate than the nuchal test.
Further testing such as CVS and amniocentesis are invasive and have risk factors associated with them.

How does the Genesis Serenity test differ from other NIPTs on the market?

Clinical evidence shows that the failure rate of Genesis Serenity test is the lowest at 0.07%. Additionally, the false positive and false negative rates are exceptionally low. More information is available on the test provider’s website (http://www.genesis-serenity.com)
Our dedicated and experienced team work in CPA accredited labs in London, ensuring that your results are returned to you faster than many of other NIPT providers who send samples to the United States or China for analysis.

The technology

Genesis Serenity® uses the verifi® technology developed by Illumina and licensed to Genesis Genetics, called “massively parallel DNA sequencing” to count the number of copies of fetal chromosomes in maternal blood. It then uses a calculation method to determine if there are too many or too few copies of chromosomes 13, 18 and 21 present in your fetus. The verifi® test has been scientifically shown to be the most sensitive and accurate non-invasive prenatal screening test available.