Patient information
Harmony Prenatal Test
Clear answers are everything when you’re pregnant, especially when it comes to your baby.
You want the best information, so you can make plans and have peace of mind for the months ahead. The Harmony test is the most proven brand of noninvasive prenatal test (NIPT) available.1 It has been used in more than 1 million pregnancies worldwide.2
For clear answers
Screening with the Harmony test identifies more than 99% of pregnancies with Down syndrome, whereas traditional screening misses as many as 20% (1 in 5).3
For fewer false alarms
The Harmony test performance is superior to traditional screening for Down syndrome.3
For information you can trust
All results will be given to you by your healthcare provider and will be interpreted in the context of your medical details and family history. You should continue with your usual scan appointments before and following the testing. The Harmony prenatal test offers a highly accurate and proven screening test1, giving confidence in the result.
With the Harmony test, there is less chance your doctor will recommend follow-up testing due to a false-positive result, and you may avoid needless anxiety.4
What is the Harmony prenatal test?
Harmony is a non-invasive blood test that screens for specific chromosome conditions in a pregnancy as early as 10 weeks gestation.
When you’re pregnant, your blood contains tiny amounts of your baby’s DNA. The Harmony prenatal test looks at this DNA to provide accurate information about the likelihood for the most common chromosome conditions such as Down syndrome (trisomy 21), trisomy 18, and trisomy 13.
What else can the Harmony test do?
In addition to screening for the conditions listed above, you and your healthcare provider can talk about which of the following additional options might make sense for your pregnancy.
Fetal sex – So you know whether your baby is male or female (also available with twins)
Monosomy X – Also called Turner syndrome, a condition where a female is missing an X chromosome, and as a result, may have heart, endocrine, and learning problems
Sex Chromosome Aneuploidy – Differences in the number of X and Y chromosomes which can result in certain learning and/or behavioral challenges in addition to other health issues.
Who should have NIPT?
The Royal College of Obstetricians and Gynaecologists welcome the news that non-invasive prenatal testing has been recommended for high chance women on the NHS and states that it reduces unnecessary invasive procedures.5
Chromosomal conditions like Down syndrome do not typically run in families and can happen in any pregnancy. Although the chance of having a baby with Down syndrome increases with age, most babies with Down syndrome are born to women under 35.6
Roche patient video for Harmony Prenatal Test
1
At 10 weeks or later, your blood is drawn.
2
Your blood sample is sent to a laboratory where it is analysed.
3
Your results are sent to your healthcare provider in 3-5 business days.
Harmony versus traditional tests for Down syndrome3
| Detection Rate* | False-Positive** | |
|---|---|---|
| Harmony Prenatal Test | More than 99 in 100 | Less than 1 in 1,600 |
| Traditional First-Trimester Screening | 79 in 100 | 1 in 20 |
*Correctly indicates a high chance for Down syndrome when it is present. **Reports a high chance for Down syndrome when it is not actually present.
For clear answers
Screening with the Harmony test identifies more than 99% of pregnancies with Down syndrome, whereas traditional screening misses as many as 20% (1 in 5).3
For information you can trust
All results will be given to you by your healthcare provider and will be interpreted in the context of your medical details and family history. You should continue with your usual scan appointments before and following the testing. The Harmony prenatal test offers a highly accurate and proven screening test1, giving confidence in the result.
With the Harmony test, there is less chance your doctor will recommend follow-up testing due
to a false-positive result, and you may avoid needless anxiety.4
For fewer false alarms
The Harmony test performance is superior to traditional screening for Down syndrome.3
Does a low chance result mean that the baby does not have Down Syndrome?
No, any screening test carries a chance of a ‘false negative’ however the chance of this happening with the Harmony is much lower than with conventional Down screening.
If I have a high chance result does that mean that the baby’s chromosomes are abnormal?
No, not necessarily. It means that there is a higher chance and you will be offered the option of amniocentesis to assess the chromosomes directly. You will be offered support and counselling to help you reach that decision.
What if I have twins?
The Harmony Non Invasive Prenatal Test and technology can also be applied to twin pregnancies but is not suitable in the case of a vanishing twin.
Will I always get a result?
3 out of 100 women will require a repeat test. When the test is repeated, we receive a result in approximately two thirds of these samples. Patients will not be charged if we are unable to obtain a result.
Is this test available through the NHS?
Since 2021 NIPT has been available and funded through the NHS as a reflex test for women who receive a higher chance result of >1:150 from a previous screening test (combined or quad test). TDL Genetics is one of three laboratories chosen to provide this testing in England. The Harmony test has been approved by PHE (now UKHSA) for use for this national screening programme. Women with a lower chance result or who require testing earlier in gestation will not be eligible for NIPT via the national screening programme.