The Harmony Prenatal Test is a screening test that determines whether or not your baby has chromosomal abnormalities. Read our review to find out how the test works.
What is the Harmony Prenatal Test?
Do you want to know more about your baby before he or she is born? The Harmony Prenatal Test promises to help you do that. The prenatal test is offered by Ariosa Diagnostics. The test is able to screen your developing baby for the risk of chromosomal abnormalities.
As early as 10 weeks into a pregnancy, women of all ages are able to determine whether or not their child is at a high risk for chromosomal conditions – including down syndrome (trisomy 21), Edward syndrome (trisomy 18), and Patau syndrome (trisomy 13).
The test isn’t some invasive, scary procedure: instead, it’s just a straightforward blood draw. After the test is complete, the results are sent to your healthcare provider.
How Does the Harmony Prenatal Test Work?
Taking the test involves a simple blood draw.
Testers will then analyze the pregnant woman’s blood. During pregnancy, fragments of the baby’s DNA will be found in the mother’s blood. The test analyzes and measures this DNA in order to predict the risk of chromosomal conditions.
The Harmony Prenatal Test is known for having a high detection rate and lower false-positive rate. Ariosa Diagnostics’s official website reports that,
“In the New England Journal of Medicine’s NEXT (Non-Invasive Examination of Trisomy) Study — the largest study of its kind —the Harmony Non-Invasive Prenatal Test was compared to First Trimester Combined Screening (FTS**) tests and was found to be have significantly better detection rate and false-positive rate. The Harmony test gives you the confidence you want in your results.”
To date, the test has been performed over 500,000 times around the world. It’s also the only NIPT validated in the general pregnancy population.
Ariosa Diagnostics compares the accuracy of its test to traditional chromosomal screening tests. Traditional tests have a false positive rate of about 1 in 20 and a detection rate of 79 out of 100. Meanwhile, the Harmony Prenatal Test has a false positive rate of less than 1 in 1600 and a detection rate of more than 99 in 100. In some studies – like for trisomy 21 detection (down syndrome) – the test had a 100% accuracy rate.
Like with most other chromosomal screening tests, the test involves analyzing the DNA for any signs of abnormalities. Ariosa Diagnostics goes into further detail about the science and technology behind their DNA scanning process here.
How to Take the Harmony Prenatal Test
Here’s how the process breaks down in step by step form:
Step 1) A blood sample is taken from the expecting mother at 10 weeks or later
Step 2) The blood sample is sent to the Harmony laboratory, where it is analyzed and tested
Step 3) Results are sent to your health care provider within 5 to 7 days of the lab receiving the sample
That’s it. It’s a straightforward procedure. The test claims to have been extensively tested in women both under the age of 35 and over the age of 35.
In addition to screening for chromosomal conditions, the Harmony Prenatal Test can indicate fetal sex (also available with twins), monosomy X, and the sex chromosomes aneuploidy panel (which identifies an abnormal number of sex chromosomes).
Harmony Prenatal Test Pricing: How Much Does It Cost?
Ariosa Diagnostics claims that “many U.S. insurance plans include coverage of the Harmony Prenatal Test.” However, they do caution that most insured patients will pay some cost for Harmony. The company also offers three assistance programs, including a patient protection program, financial assistance program (to those who qualify regardless of insurance status), and a prompt pay program (a discount for expectant parents who pay their bill within 30 days).
Nevertheless, based on our research online, it seems like most insurance companies do not offer coverage for the Harmony Prenatal Test.
Typically, patients report a price of $795 for the test.
About Ariosa Diagnostics
Ariosa Diagnostics Inc. is a molecular diagnostics company that operates a CLIA laboratory. The company performs a wide variety of tests involving the analysis of cell-free DNA in blood.
The company is based in San Jose, California. In 2015, Ariosa Diagnostics was acquired by Roche.
You can contact Ariosa Diagnostics by phone at 1-855-927-4672 or by email at [email protected]. These are customer service contact lines typically used by patients who have already undergone the Harmony Prenatal Test.
Sohuuld You Undergo the Harmony Prenatal Test?
The Harmony Prenatal Test is a highly accurate test you can use to assess your baby’s risk of developing Down syndrome or some other chromosomal condition. It’s primarily targeted towards women over 40 – although it’s available to women of all ages and demographics.
The test is priced at $795. Most insurance plans do not appear to cover the test. The test involves taking a blood sample, sending that sample to Ariosa Diagnostic, and then waiting 5 to 7 days for the sample to be tested.
Overall, the Harmony Prenatal Test is a straightforward procedure that can put your mind at ease – or alert you of upcoming chromosomal problems. Talk to your doctor to find out if the Harmony Prenatal Test is the right choice for you.
