The Harmony test is a non-invasive, cell-free DNA-based blood screening test that assesses the probability of fetal trisomy 21, 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 21.1
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.
Yes. Harmony includes the option of testing for sex chromosome aneuploidies ( monosomy X, XXX, XXY, XYY, and XXYY) and 22q11.2 deletion.
Following confirmation of a pregnancy, order the Harmony test as early as 10 weeks gestational age. Administer a simple blood draw directly or through a participating laboratory and send it to Ariosa Diagnostics using the specimen collection and transportation kit. Receive a report detailing test results in as little as 3 days, most in 5 days after sample receipt. The Harmony test can be used in conjunction with NT ultrasound. Patient education is similar to that required for conventional trisomy screening tests.
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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, recent 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.2
The Harmony test is validated for singleton, twin, and IVF pregnancies (including self and non-self egg donor pregnancies).11
View our list of studies.
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 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.
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.1-2 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.
iPPV value for trisomy 21 in a 35-year old population, incidence of 1/249.
iiPPV value for trisomy 21 in a general population (18-48), incidence of 1/417.
At 10 weeks' gestational age, a patient can request the Harmony Prenatal test.
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%.3
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 21.1
See details about the technology that underpins the Harmony test.
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.
†Both under 35 and over 35 age groups, studies have included women ages 18-48