Find answers to your questions. We are here to provide all the information you need.
Q: What is the Harmony non-invasive prenatal test?
A: The Harmony test is a non-invasive, cell-free DNA-based blood screening test that assesses the probability of fetal trisomy 21 (Down Syndrome), 18, and 13 in women of any age or risk factors†. Harmony has a detection rate of greater than 99% and a false-positive rate of less than 0.1% for trisomy 21 (Down Syndrome).1,2
The Harmony test can be performed as early as 10 weeks’ gestation, and results are received in as soon as 3 days, most in 5 days after sample receipt.
Harmony uses a directed (targeted) approach, analyzing only the chromosomes of interest.
† Both under 35 and over 35 age groups, studies have included women ages 18-48
Q: Does the Harmony prenatal test assess risk for other genetic conditions in addition to trisomies 21, 13, and 18?
A: Yes. Harmony includes the option of testing for sex chromosome aneuploidies (monosomy X, XXX, XXY, XYY, and XXYY) and 22q11.2 deletion.
Q: How do I incorporate the Harmony prenatal test into my practice?
A: Following confirmation of a pregnancy, order the Harmony test as early as 10 weeks gestational age. Your office or practice laboratory can collect a simple blood specimen and send it to an approved laboratory. Collection and transportation kits are available. You will receive a report detailing test results from your laboratory. The Harmony test can be used in conjunction with NT ultrasound. Patient education is similar to that required for conventional trisomy screening tests.
Q: How do I order the Harmony prenatal test?
Fill out the contact form on our Get Started page.
Q: Is the Harmony prenatal test validated for use in pregnancies of any age or risk?
A: Yes. The Harmony prenatal test is validated for pregnant women of any age or risk categories, including both under 35 and over 35 age groups (studies have included women ages 18-48). In fact, a landmark study published in the New England Journal of Medicine showed that Harmony significantly outperformed first trimester screening in both trisomy 21 detection rate and false-positive rate.1,2
The Harmony test is validated for singleton, twin, and IVF pregnancies (including self and non-self egg donor pregnancies).3
View our list of studies
Q: What is the false-positive rate of Harmony prenatal test for trisomy 21?
A: The false-positive rate for the Harmony test was less than 0.1% in blinded prospective studies of over 22,000 pregnant women ages 18-48.1,2 False-positive rates for most conventional screening tests are generally around 5%.3
Read more about the accuracy of the Harmony test versus other first trimester screening methods.
Q: What is the positive-predictive value (PPV) of the Harmony prenatal test for Down’s Syndrome?
A: For trisomy 21, the Harmony test has been shown to have a PPV of 93% in the high-risk populationi and 81% in the general populationii in blinded published studies.1-3 Positive predictive value (PPV) is the probability that a positive test result is a true positive result. In contrast, first trimester serum screening has a PPV of 6% in the high-risk population or in a 35-year-old population.
Read more about the PPV of the Harmony test versus other first trimester trisomy screening methods.
i PPV value for trisomy 21 in a 35-year old population, incidence of 1/249.
ii PPV value for trisomy 21 in a general population (18-48), incidence of 1/417.
Q: How early can the Harmony prenatal test be performed?
A: At 10 weeks' gestational age, a patient can request the Harmony prenatal test.
Q: How is the Harmony prenatal test different from conventional trisomy screening tests?
A: The Harmony test is a screening test that delivers clear answers as early as the first trimester with a single blood draw. Other conventional tests for Down syndrome are performed later in pregnancy and may require multiple office visits. Traditional serum screening tests are associated with a false-positive rate as high as 5%.1
The Harmony test uses a unique method of targeted DNA analysis that, combined with extensive quality controls, achieves over 99% in detection rate and a false-positive rate of less than 0.1% for trisomy 21.2,3
Q: How is the Harmony prenatal test different from other cell-free DNA (cfDNA) tests?
A: Only the Harmony test uses a unique targeted approach (DANSRTM and FORTETM) to more accurately assess the chromosomes of interest.
Read more about how the Harmony test differs from other cfDNA-based tests.