The Harmony Prenatal Test Explained

By Ashley Thorne

January 21, 2019

The Harmony Test Explained

Once you are pregnant, it seems as though there are so many new things to take in!  Your health care provider explains so much, but it can still feel overwhelming if you’ve never been pregnant before.  At The Mama Coach, our aim is to inform you the best we can!  If you have or haven’t heard of The Harmony Prenatal Test before, and want to learn more, this article is for you!

What is this test?

The Harmony Prenatal Test is a fairly new form of Non-Invasive Prenatal Testing (NIPT).  As this site explains, this test screens for trisomy 21 (Down syndrome), trisomy 18, as well as trisomy 13.  This test is also able to detect when there is an extra chromosome present (an example being Klinefelter syndrome), as well as when a small part of chromosome 22 has been deleted (22q11.2 microdeletion).  Furthermore, this particular NIPT is also able to screen for Monosomy X (Turner syndrome) and also allows parents to find out the sex of the developing fetus from very early on in the woman’s pregnancy.

How does this test screen for all of this?

This test looks at the amount of cell-free fetal DNA that is circulating in the mother’s bloodstream.  Cell-free fetal DNA is genetic material from the placenta (so does not come directly from the fetus itself), but still generally represents the genetic profile of the fetus .  This genetic material is released by the placenta into the bloodstream of the mother in small amounts early on in pregnancy and increases as the mother’s pregnancy progresses.  Once the cell-free fetal DNA is purified from the mother’s blood, this test is than able to find defects in the developing fetus’ DNA.  To learn more, check out this site.

How is it done?

A blood sample is drawn from a vein in the mother’s arm.

When is it done?

At the earliest, this blood test can be done ten weeks into a woman’s pregnancy.

How soon are results back?

Usually seven to ten business days after a woman’s bloodwork has been drawn, her health care provider would have her results.

How accurate is this NIPT?

This particular NIPT is over 99% accurate in detecting Trisomy 21, approximately 97% accurate for detecting Trisomy 18, and approximately 93% for Trisomy 13 as explained here.

What is the false-positive rate of the Harmony Prenatal Test in comparison to traditional first trimester screening?

Comparing the two, 1 in 1000 women will have a false-positive result with the Harmony Prenatal Test, where as 1 in 20 women will have a false-positive result with the traditional first trimester screening as noted on this site.  The false-positive rate of the Harmony Prenatal Test is less than 1% for all three chromosome conditions.

Is this test part of traditional prenatal blood work done in the first trimester?

This test is not part of traditional prenatal blood work that is done in the first trimester.  This is NOT a mandatory test for an expecting mother to have done.

Is this test free?

For women in Ontario and British Columbia, who meet certain criteria, this NIPT is one that is publicly funded.  There are also some health insurance companies that will cover the cost of this NIPT.  If you are someone who is not covered at all, but would still like to have this test done, you can do so by purchasing a Harmony Prenatal Test for approximately $500.00, as described here.  This payment does not go to your health care provider.  Your health care provider would give you the kit in a small box and you would take this kit to the laboratory where you will have your bloodwork done.  You would also make this payment right there at the lab.  Also, as part of this cost, Dynacare has a customer care program that includes genetic counseling for those who would like this.

Can any pregnant woman have this test done?

Yes, any pregnant woman can have this test done.  It does not matter whether a woman has an average or high-risk pregnancy because in both cases, this test has proven itself with excellent performance.  This means that a woman could be carrying twins or may have required fertility treatment to become pregnant (in vitro fertilization, donor sperm, surrogacy) and she would be able to have this test done, if desired.

Has this NIPT been well studied?

It turns out that the Harmony Prenatal Test has been so well studied that it is the most studied NIPT in the world.  It is also the most proven NIPT in the world, currently.  Over 22,000 women have been involved in clinical trials for this NIPT.  These women are comprised of different ages and pregnancy risk levels.

Can the Harmony Prenatal Test tell you for sure whether your baby has one of the above mentioned chromosome conditions?

Although this screening test is more accurate than the traditional first trimester screening, it can not tell you 100% whether or not your baby has one of the above mentioned chromosome conditions.

What types of extra testing would be recommended if the results came back as a high chance?

It would be recommended that a diagnostic test such as an amniocentesis or chorionic villus sampling (CVS) be performed.  An amniocentesis is 100% accurate.

Why have the Harmony Prenatal Test done prior to an Amniocentesis?

If an amniocentesis is more accurate, than you may wonder why you would even have the Harmony Prenatal Test done at all.  The Harmony Prenatal Test can be done after traditional first trimester screening, if any results should come back indicating that the fetus has a high chance of having a chromosome condition.  The Harmony Prenatal Test may than rule out any false-positives (which has zero risk to the developing fetus) and the woman would than not have to have an amniocentesis done.  With an amniocentesis there is a risk to the pregnancy and it is estimated that there is a 1 in 200 pregnancy loss with an amniocentesis.

I hope this article answered all the questions you may have had regarding the Harmony Prenatal Test.  For more information regarding this NIPT, you can always consult your health care provider, as well.

If you ever have questions regarding anything pregnancy or motherhood, reach out to a  Mama Coach near you! We would love to help you!

 

 

 

 

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