About Harmony Prenatal Test
The Harmony Prenatal Test uses a unique targeted DNA analysis method to help you screen your unborn child for chromosomal abnormalities in as early as 10 weeks. Harmony can also evaluate fetal sex and the number of X and Y sex chromosomes, in just three steps:
- A maternal blood sample is taken at 10 weeks or later.
- Your blood sample is sent to the Harmony laboratory, where it is analyzed.
- Your results are sent to your healthcare provider within 5-7 days from sample receipt.
In addition to its ease of use, Harmony claims their Prenatal Test is more accurate than traditional screening tests, so it can provide “clear answers to questions that matter.”
Just because Harmony is easy and accurate though, does this necessarily mean it’s the right prenatal test for you? How much does it cost? Are there other options? Let’s start answering your important questions by taking a look at how Harmony works.
How Does the Harmony Prenatal Test Work?
This is a simple question with a not-so-simple answer, so let’s break everything down.
The Role of Chromosomes
Inside the nucleus of each of our cells are threadlike structures called chromosomes, which are made up of tightly coiled DNA (the blueprint that allows you to develop and reproduce). When a cell divides, it’s the chromosome’s job to make sure all the genetic information contained in DNA is perfectly copied to the new cell.
Sometimes, however, the transcription process can go awry, whether due to the parents’ genetics, age (women over 35 have an increased risk), or family history, leaving an extra chromosome in places. This can result in conditions such as Down syndrome (trisomy 21), Edward syndrome (trisomy 18), and Patau syndrome (trisomy 13). And it’s these genetic disorders that the Harmony Prenatal Test is designed to detect.
How Does the Harmony Prenatal Test Detect Chromosomal Disorders?
Available as early as 10 weeks of pregnancy, Harmony is a non-invasive prenatal test (NIPT) that uses blood drawn from the mother to detect these chromosomal disorders.
In a nutshell, Harmony does this using the company’s proprietary DANSR™ technology, which focuses only on cfDNA (cell-free DNA; fragments of the baby’s DNA floating around in the mother’s blood) from the chromosomes of interest, as well as FORTE™, an algorithm that more clearly distinguishes high and low-risk results.
Why Is Harmony Considered a Non-Invasive Prenatal Test?
Prior to cfDNA testing, the most commonly used tests for chromosomal abnormalities were:
- Chorionic Villus Sampling (CVS) – Here, a small sample of cells is removed from the placenta. This test has a greater than 99% detection rate, although it also carries a slightly increased risk of miscarriage following the procedure.
- Amniocentesis – Here, a small sample of amniotic fluid is removed using a long needle that’s inserted through the belly. This testing method has a greater than 99.8% detection rate, but also carries a small risk for miscarriage following the procedure.
On the other hand, cfDNA tests like Harmony only involve drawing about three vials of blood, so they’re considered non-invasive, without the increased risk of miscarriage. This 9-minute video does a great job of explaining much of what you need to know:
Is Harmony Clinically Tested?
According to the published studies listed on their website, Harmony has been shown to have a greater than 99% accuracy in detecting Down syndrome cases, along with a false positive rate of less than one in 1,600 (compared to one in 20 with traditional protein-based testing). One of these included the large NEXT (Non-Invasive Examination of Trisomy) Study conducted by New England Journal of Medicine.
Along with this, the company claims Harmony has been used by clinicians to screen more than half a million worldwide pregnancies, leading to it being the most broadly studied non-invasive prenatal test available, as well as “the only NIPT validated in the general pregnancy population.”
How Do You Order a Harmony Test?
Ultimately, only your healthcare provider can determine if a Harmony Prenatal Test is right for you. However, if you’re over the age of 35 and/or have a family history of chromosomal disorders, NIPT tests like Harmony could provide especially useful insight.
Note: A Harmony test can also be used to detect fetal sex (including twins), monosomy X, and sex chromosomes aneuploidy panel.
To this extent, the company recommends speaking with your doctor and asking:
- Do you offer the Harmony test in your office or through a laboratory?
- What can I learn from the Harmony test?
- How does Harmony differ from other Down syndrome screening tests?
- How can I find out how much the Harmony test costs?
- When and how will you notify me of the Harmony test results?
After your blood has been drawn, it will be sent off to Ariosa Diagnostic, a CLIA-certified laboratory, for processing. According to the company, you can generally expect results in 7 days or less.
Is this what Harmony clients are experiencing, though? We’ll talk more about this in just a second, but first, let’s find out how much you’ll pay for one of their tests.
How Much Does the Harmony Prenatal Test Cost?
While there aren’t any prices listed on their website, it appears customers are reporting prices that range anywhere between $800 and $2,000. To complicate matters, many US insurance plans cover at least some portion of the Harmony Prenatal test, so what a patient pays out of pocket might be as varied as the population itself.
With this in mind, there are three different options for paying for your Harmony test:
- Patient Protection Program – Your private insurance pays for some or all of the cost.
- Financial Assistance Program – Ariosa Diagnostics offers a sliding fee schedule for those who qualify, regardless of insurance status.
- Prompt Pay Program – A discounted pricing program for those who pay their bill within 30 days.
If you have questions about the Harmony Prenatal Test (related to costs or otherwise), support staff can be reached at 855-927-4672.
What Happens If Your Harmony Test Is Inconclusive?
Again, there wasn’t any information on Harmony’s website about what happens if your test comes back inconclusive. However, many online patients claimed that their re-testing cost was covered by the company.
There are almost certainly many different factors that go into a decision like this though, and it’s handled on a case-by-case basis.
Now, let’s talk about client feedback.
What Are Harmony Patients Saying In Their Reviews?
If you quickly type the phrase “Harmony Prenatal Test reviews” into your favorite search engine, you’ll find thousands of pieces of in-depth feedback about the process and the results. And overall, it seems like this NIPT comes with mostly positive patient reviews, primarily based around its reputation for accurate results.
In some instances, however, it seems that patients have experienced inconclusive results due to not enough fetal DNA in blood sample, although many claim their blood was redrawn and retested without additional cost. Another common complaint was long wait times; many claimed they had to wait 15 days or longer for results.
From a company perspective, Harmony is brought to you by Ariosa Diagnostic, a CLIA-certified laboratory, who also processes all test kits.
Are There Other NIPT Kits Like Harmony?
While the specific DANSR™ and FORTE™ technologies might be unique to Harmony, the reality is that if you’re in the market for a non-invasive prenatal test, then you have several other popular options. These include Panorama, MaterniT21, Illumina, Natus, and more.
Related: Counsyl Review
Now, not all of these other NIPT services offer the same level of clinical substantiation as Harmony, but the point is that you have options. On top of this, there are more traditional options like protein-based assessments and nuchal translucency, although these are meaningfully less accurate than NIPT and come with greater instances of false positives.
Taking everything we’ve discussed so far, let’s help you come to a conclusion about the Harmony Prenatal Test.
Is the Harmony Prenatal Test Right For You?
Considering all the different factors involved in the process, only you, your loved ones, and your doctor can determine whether or not an NIPT test like Harmony is right for you. But if you’re looking for something that’s been clinically studied, used by hundreds of thousands of women, and comes with high marks from patients, Harmony certainly seems to fit the bill.
With this said, there are a couple things we think you might want to keep in mind:
First, Harmony has not been reviewed or approved by the FDA. While the company is very clear about this, given its medical nature, it might be easy to assume otherwise.
But perhaps most importantly, remember that the Harmony Prenatal test is not a definitive test or a diagnostic. Instead, it’s only intended to help your doctor decide if you need further diagnostic testing to confirm the results.
Did you use Harmony’s Prenatal Test? Did you receive inconclusive results? Was the process easy? How long was your wait? Tell us all about your experience by writing a review below!
3 out 5 people found this review helpful
Disappointing experience and a waste of money.
My experience with Harmony Prenatal testing started at their Gamma-Dynacare Medical Lab where I went to have my blood taken. It was a very unnerving experience; the clinic was dirty, disorganized and filled with people that were (self-proclaimed) drug addicts. My name was called immediately; otherwise, I would have turned around and walked out. The nurse on site was friendly and put me at ease. I live in Canada, and I had to pay $495 out of pocket for this test.
I received my results yesterday. While I was happy that the results came back low risk for trisomy 21, trisomy 18 and trisomy 13, the results for the sex of the baby came back "inconclusive." One of the reasons we were willing to pay the fee for this test was to have the opportunity to learn the baby's gender. There are FREE tests covered by OHIP that could have given us the same results regarding genetics defects.
Overall, I would say, do the tests covered by OHIP first. If those come back high risk and you're looking for a second opinion, you may want to seek out other tests. For me personally, the Harmony Prenatal Test was a total waste of time and money.
Bottom Line: No, I would not recommend this to a friend