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What is the Ariosa HarmonyTM Prenatal Test?

The Ariosa HarmonyTM prenatal test is a new option in prenatal screening for Down’s syndrome (trisomy 21), Edward’s syndrome (trisomy 18), Patau’s syndrome (trisomy 13), and also fetal sex (X and Y) chromosome conditions and works by analysing cell-free DNA circulating in the pregnant mother’s blood.

It is non-invasive and therefore does not carry a risk of miscarriage or a risk of other adverse outcomes that may be associated with invasive testing such as chorion villus sampling (CVS) or Amniocentesis.

Who can have the HarmonyTM Test?

Any woman who requires more reassurance about the normality of their pregnancy can have the HarmonyTM Test.

Women may also choose to have the test because they are concerned about their age or previous obstetric history i.e. they may have already had a chromosomally abnormal pregnancy or have a history of miscarriage & therefore prefer to avoid an invasive test.

The test can be performed for any singleton pregnancy including those conceived through IVF with an egg donor. It can also be performed for all twin pregnancies without X or Y (fetal sex) conceived either naturally or through IVF using the patient’s own eggs or with an egg donor.

When can the HarmonyTM Test be performed?

It can be performed from 10 weeks gestation and requires a blood test from the mother and an ultrasound scan.

For all bookings within the Nuchal scan period (11+1 – 13+6 weeks) a Harmony + Nuchal will be performed at the same time unless you already have had a Nuchal scan.

How accurate is the HarmonyTM Test?

In singleton pregnancies the test identifies more than 99% of fetuses with trisomy 21, 98% of fetuses with trisomy 18, 80% of fetuses with trisomy 13, and 96% of fetuses with Turner’s syndrome. The accuracy for X and Y analysis (fetal sex) is above 99%. The accuracy for detecting other sex chromosome anomalies varies by condition.

How long do the results of the HarmonyTM Test take?

The results are usually ready within a week and will give a ‘low’ or ‘high’ risk result. A ‘high risk’ result is indicative of a high risk for a trisomy.

What happens if the result of the HarmonyTM Test is ‘high risk’

If the test result shows that there is a ‘high risk’ that the fetus has Down’s syndrome (trisomy 21), Edward’s syndrome (trisomy 18), Patau’s syndrome (trisomy 13) or sex chromosome conditions it does not mean that the fetus definitely has one of these conditions, although it is highly likely.  For this reason, in the event of a ‘high risk’ result, an invasive procedure (CVS or Amniocentesis) will be recommended.

Similarly if the test results show that there is a ‘low risk’ that the fetus has Down’s syndrome (trisomy 21), Edward’s syndrome (trisomy 18), Patau’s syndrome (trisomy 13) or sex chromosome conditions it is unlikely that the fetus has one of these conditions. However, there is a very small risk that not all trisomy fetuses will be detected.

Do I still need to have the nuchal scan & blood test and anomaly scan after having the HarmonyTM Test?

It is important that both the nuchal scan & anomaly scan are carried out after having the HarmonyTM test.

The nuchal scan at around 12 weeks gestation will include a more detailed examination of the fetal anatomy, including measurement of the nuchal translucency and nasal bone. Structural abnormalities such as Spina Bifida, heart defects and slower growth of the baby will only be seen on ultrasound scan and often not until later on in the pregnancy during the anomaly scan.

How much does the HarmonyTM Test cost?

The cost for a first trimester test is £495.

Harmony + Nuchal scan £595

If you have had a previous pregnancy with a chromosome abnormality or a ‘high risk’ result from either nuchal screening, the triple or quad test, or an abnormal scan result prior to having the HarmonyTM Test, there will be an additional consultation fee of £50.

Please contact us for further information or to make an appointment.

Please click on the links below for more information or to see an animated video:-

TDL Patient Information Leaflet

Arisosadx.com

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