Developed in USA by Ariosa Diagnostics Ltd
, the new Harmony Test is a non invasive blood test for pregnant women from 10 weeks of pregnancy with a 99% detection rate for Down Syndrome. It has been found that about 10% of the DNA circulating in blood of a pregnant women is from the pregnancy itself. Therefore by taking a simple blood sample from the mother, it is now possible to test for conditions like Down Syndrome in her unborn baby.
Harmony Test in the UK
The Harmony blood test was piloted by the Fetal Medicine Foundation
in September 2012 and was introduced by The Doctors Laboratory
in December 2012. Dr. Lisa Levett
, director of TDL Genetics, said: "Non-invasive prenatal testing is one of the most exciting and important developments in this field in the last 50 years. Our laboratory has always been at the forefront of the latest prenatal diagnostic technology – for example, we developed the first rapid PCR-based prenatal Down syndrome test, Amnio-PCR or qf-PCR. We are delighted to be working with Ariosa to bring the non-invasive Harmony™ Prenatal Test to the many doctors and hospitals we work with in the UK and overseas."
The UK Harmony Test Network
In January 2013 a network of centres Harmony Test in the UK was launched so that pregnant women and their partners could easily access information about this new technology and the test itself.
Who is it suitable for?
The Harmony Test is suitable for any pregnant woman with a singleton pregnancy (or twin pregnancy if a natural conception or IVF etc with her own eggs) who wants a safe, reliable, early and accurate test for Down Syndrome. The test will also identify most cases of Edward Syndrome and Patau Syndrome.
Typically the test is useful for the following patients:
1) Women over 35 who are concerned about their age related risk of Down Syndrome and other Trisomies.
2)Women under 35 who want a safe, reliable, early and accurate test for Down Syndrome
3)Women who have an increased risk or "High Risk" result from a Combined Test or Nuchal Translucency scan but wish to avoid unnecessary CVS or amniocentesis and their risk of miscarriage.
4)Women who have an increased risk or "High Risk" result from a Triple test or Quad test but wish to avoid unnecessary CVS or amniocentesis and their risk of miscarriage.
5)Women with a previous pregnancy with a baby with Down Syndrome, Patau Syndrome or Edward Syndrome
6)The test is valid for IVF, ICSI and surrogate pregnancies even if Donor Eggs have been used (update Feb 2013).
What does it test for?
• Trisomy 21 is the most common trisomy at the time of birth. Also called Down Syndrome, it is associated with moderate to severe intellectual disabilities and may also lead to digestive disease and congenital heart defects and other malformations.
• Trisomy 18 (Edward Syndrome) and Trisomy 13 (Patau Syndrome) are associated with a high rate of miscarriage. These babies are born with severe brain abnormalities and often have congenital heart defects as well as other birth defects. Most affected individuals die before or soon after birth and very few survive beyond the first year of life.
• Turner Syndrome(only singletone pregnancies)
• Fetal sex (only singletone pregnancies)
How accurate is the test?
Clinical studies have shown exceptional accuracy for detecting fetal trisomy.
A ‘HIGH RISK’ result is indicative of a high risk for a trisomy. The test identifies more than 99% of fetuses with trisomy 21, 98% of fetuses with trisomy 18, and 80% of fetuses with trisomy 13. After the test, the number of women required to have a CVS or an amniocentesis is less than 1%. It is important to note that if the test results show there is a HIGH risk that the fetus has trisomy 21, 18 or 13 it does not mean that the fetus definitely has one of these defects , although it is highly likely. For this reason, in the event of a ‘high risk’ (or positive) result, follow-up testing by an invasive procedure is recommended.
In the same way if the test results show that there is a ‘LOW RISK’ that the fetus has trisomy 21, 18 or 13 it is unlikely that the fetus has one of these defects. However there is a very small risk that not all trisomy
fetuses will be detected.
Fetal sexing in singleton pregnnacies is about 99% accurate.
All results should be interpreted by a clinician in the context of clinical and familial data: patients should continue with their usual scan appointments following testing.
How long will it take to get results?
Typically within 2 weeks but occasionally if there is not enough fetal DNA in the original blood sample then a repeat blood test may be required within about a week of the original test at no extra cost. This occurs in about 3% of pregnancies. If a second test is required then about 2% of all women are still left with no result. They would be then be offered an amniocentesis at no extra cost.
Who is the test not suitable for?
The test is not suitable for multiple pregnancies where donor eggs have been used. .
Are there any risks to the pregnancy from the Harmony Test?
No. The testing is non-invasive: it involves taking a blood sample from the mother. The pregnancy is not put at risk of miscarriage, or from other adverse outcomes that are associated with invasive testing procedures such as CVS or amniocentesis.
Where can I get more information about the Harmony Test
Click here to DOWNLOAD
our Harmony Test information leaflet.
Where can I get a Harmony test?
Simply look up your nearest centre in the directory below and click on the link to go to their website.
Glasgow Centre for Reproductive Medicine (GCRM) Glasgow. wwwgcrm.co.uk
Tel: 0141 8918749.
Early Scan included but not confirmation amnio/CVS included £750
Innermost Secrets Wales Cardiff www.innermostsecrets.com
Tel: 0345 2303386. Early Scan and if required confirmation amnio/CVS included £750
Beard Mill Clinic Oxon. www.beardmillclinic.com
Tel: 01865 301537. Early Scan included but not confirmation amnio/CVS included £750
Tel: 020 7908 3878 Early Scan included but not confirmation amnio/CVS included £750
Tel: 0207 7250528 Early Scan included but not confirmation amnio/CVS included £600