Questions and answers for expecting parents

A: When you are pregnant, your blood contains pieces of DNA from your developing baby known as fetal cells. The Harmony prenatal test analyzes this fetal DNA in a sample of your blood to assess the chance of Down syndrome (trisomy 21) and other chromosome conditions called Edwards syndrome (trisomy 18) and Patau's syndrome (trisomy 13).

A:  Using a DNA-based technology, the Harmony prenatal test has been shown to identify more than 99% of pregnancies with Down syndrome.¹ By comparison, traditional blood tests can miss as many as 15% of pregnancies with Down syndrome.²

The Harmony prenatal test is also much less likely than traditional tests to give you a false-positive result, meaning there is much less chance your doctor would recommend follow-up invasive testing like amniocentesis.

The Harmony prenatal test is a screening test. Results should be confirmed with diagnostic testing such as amniocentesis and chorionic villus sampling (CVS).

Read more about the accuracy of the Harmony prenatal test.

References

1. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6
2. ACOG 226. Obstet Gynecol. 2020 Oct;136(4):859-867.

A: The Harmony prenatal test delivers clear answers as early as the first trimester with a single blood draw. Other screening tests for Down syndrome are performed later in pregnancy and require multiple office visits. Traditional 1st trimester serum screening tests are associated with a false-positive rate as high as 5%.¹

The Harmony prenatal test uses a unique method of targeted DNA analysis that, combined with extensive quality controls, achieves over 99% detection rate and a false-positive rate less than 0.1%.²

References

1. ACOG 226. Obstet Gynecol. 2020 Oct;136(4):859-867.
2. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6.

A: Yes, the Harmony prenatal test has the option to evaluate fetal sex and sex chromosome aneuploidy (monosomy X, XXX, XXY, XYY and XXYY). It can also screen for 22q11.2 microdeletion.

A: Yes. Professional society guidelines support the offering of non-invasive prenatal testing to the general population.^1,2,3 The Harmony prenatal test has been extensively validated in women both over and under 35.⁴ Most babies with Down syndrome are born to women who are less than 35 years old, even though the chance for Down syndrome in a pregnancy increases with a woman’s age.³

References

1. Hui et al. Prenatal Diagnosis. 2023 June;43(7)814-828.
2. Dungan et al. Genet Med. 2023 Feb;25(2):100336.
3. ACOG 226. Obstet Gynecol. 2020 Oct;136(4):859-867.
4. Norton et al. New England J of Medicine. 2015; 372(17):1589-1597.

A:  As early as 10 weeks into your pregnancy, you can take the Harmony prenatal test with a simple blood draw.

A: Please follow-up with your healthcare provider on the timeline for receiving your results.

A: You can find more information on trisomy 21, trisomy 18 and trisomy 13 in the "What does Harmony test for" section. 

A: Yes. Harmony prenatal test can be used in twin pregnancies for trisomies 21, 18 and 13 and to evaluate the sexes of the babies. Sex chromosome aneuploidy and 22q11.2 microdeletion cannot be tested for in twin pregnancies.

A: Yes. In most cases, the Harmony prenatal test can be used in pregnancies conceived through in vitro fertilization (IVF), including those using an egg donor.

A:  For questions that relate to your specific case and personal concerns, it’s best to talk to your healthcare provider. Here is a list of questions for your healthcare provider that you can print for your next visit.