Harmony test: Everything parents-to-be need to know

The first few weeks of pregnancy are filled with excitement, anticipation, and many questions. During this time, parents-to-be often turn to prenatal tests for answers about their baby's health. These tests offer early insights and help prepare you for what's ahead.

One of the popular tests many parents consider is Harmony, a non-invasive test that checks for common genetic conditions. If you're considering taking the Harmony test, we’ll walk you through how it works, its accuracy, and how it can help you make a confident, informed decision.

What is the Harmony test? 

The Harmony test is a non-invasive prenatal test (NIPT) that screens for certain genetic conditions in a developing baby. It works by analyzing tiny pieces of a baby’s DNA that naturally float in the mother’s blood during pregnancy.

The test was developed by Roche, a well-known biotechnology company, and screens for common chromosomal conditions like:

• Down syndrome (Trisomy 21)

• Edwards syndrome (Trisomy 18)

• Patau syndrome (Trisomy 13)

Besides these, the test also checks for conditions related to differences in the number or structure of the sex chromosomes, such as Turner or Klinefelter syndrome, as well as a few rare microdeletions like 22q11.2 deletion syndrome (also called DiGeorge syndrome).

Lastly, the Harmony prenatal test is also frequently used by parents who want to find out their baby’s sex early on.

Bonus read — Learn more about NIPTs and prenatal screening from these helpful articles:

• How long do NIPT results take?

• Cell-free DNA test vs. NIPT

• Prenatal genetic testing pros and cons

How does the Harmony test work?

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The test is quick and simple, similar to getting a routine blood test. Here’s what usually happens:

• You provide a blood sample: A small sample is taken from your arm with a quick pinch. You don’t need to fast or do anything special beforehand, so you can eat and drink normally.

• The DNA gets analyzed: Your sample goes to a lab where the baby’s cell-free DNA is carefully analyzed. The test uses a method called DANSR (digital analysis of selected regions) to focus on specific parts of the DNA, helping give an accurate picture.

• You get your results: Within 5–10 days, you’ll get a report that tells you if there’s a low or high chance of certain conditions, or if the results are unclear. If you have questions, your doctor or genetic counselor can help explain what it all means and discuss what to do next.

Harmony test: 4 factors you should consider before taking it

Deciding on prenatal tests can feel overwhelming, especially when there’s so much to think about.

To help you feel more confident and informed, we’ve highlighted four important things to keep in mind about the Harmony test:

1. When can you take the Harmony test?

2. Who can take the Harmony test?

3. How accurate is the Harmony test?

4. Understanding the cost and insurance coverage

1. When can you take the Harmony test?

You can take the Harmony test as early as 10 weeks into your pregnancy. By this point, there’s usually enough fetal DNA in your bloodstream for an accurate analysis. This early timing means you get insights sooner than with some other prenatal tests, which often cannot be taken before the second trimester.

If you're past the first trimester, you can still take it later in pregnancy — your doctor can help you decide on the right time. This way, you can balance getting timely information with your own personal readiness and any other prenatal appointments you have planned.

Bonus read — See how first-trimester screening and NIPT compare to understand the differences and find the best option.

2. Who is the Harmony test for?

The Harmony NIPT test is a helpful option for many expectant parents wanting early insight into their baby’s health. While it’s available to anyone who’s pregnant, it may be especially useful if:

• You’re 35 or older, as the chance of certain chromosomal conditions increases with maternal age.

• There’s a family history of genetic conditions, and you want to understand your risks better.

• You’ve had a previous pregnancy affected by a genetic condition, which could raise the risk in this pregnancy.

• Earlier ultrasounds or standard screenings flagged something you’d like to explore more deeply.

• You’re looking for a non-invasive screening that offers greater accuracy compared to traditional first-trimester tests.

While Harmony is a screening tool that helps identify potential risks, it doesn’t provide a definitive diagnosis. If you want a test that can confirm genetic conditions, or if you have specific concerns, your healthcare provider may recommend diagnostic tests like amniocentesis or chorionic villus sampling (CVS). These options might be more suitable depending on your personal or family medical history.

3. How accurate is the Harmony test?

Source: Vika_Glitter

Roche claims Harmony is one of the more accurate NIPTs available. Studies show it can detect over 99% of Down syndrome (trisomy 21) cases, with a very low false-positive rate (under 0.1%).

When you get your Harmony test results, they’ll usually fall into one of three categories:

1. Low-risk: This means your baby is unlikely to have any of the conditions the test looks for.

2. High-risk: This means there’s a higher chance your baby may have a condition, but it’s not a diagnosis.

3. Inconclusive: Sometimes, the test can’t provide clear results. In such cases, you can take the test again.

Harmony may have a very low false-positive rate, but it can still happen. Certain things can affect the accuracy of your results, such as:

• Low fetal fraction: If fetal DNA makes up less than about 4% of your sample (often because the test was done before 10 weeks), results may be unclear or less reliable.

• High maternal BMI: Higher maternal weight can dilute fetal DNA in your blood, which can make the test less accurate or harder to interpret.

• Multiple pregnancies: With twins or more, the test can’t always tell which baby the DNA came from, which can affect the results.

• Use of donor eggs: If the genetic material comes from a donor, it can make the test analysis more complicated if this isn’t properly considered.

• Sample handling: Though rare, mistakes when collecting, transporting, or processing the sample can affect accuracy.

If you receive a high-risk result, talk with your doctor before drawing any conclusions. They’ll usually recommend follow-up diagnostic tests such as amniocentesis or CVS. Consulting with a genetic counselor can also provide valuable support and help you understand what the results mean for your pregnancy.

4. Understanding the cost and insurance coverage 

Roche doesn’t list the exact price of Harmony on the official website and instead suggests you talk to your healthcare provider to get the details about cost and access.

Here are some factors that can affect the overall cost of this test:

• Which version of the test you get: Some tests screen for the most common conditions, while others look for more. Naturally, the more conditions the test checks for, the more you’ll end up spending on it.

• Your insurance: Many healthcare insurance plans cover the test if it’s medically necessary, but coverage and out-of-pocket costs can vary.

• Where you get the test: Different labs or clinics may charge different amounts, and public insurance like Medicaid may cover it only for higher-risk pregnancies.

Because billing and coverage can be confusing, it’s always best to check with your healthcare provider, your insurance company, and even the test provider directly before you take the test. This can help you avoid surprises and find out if financial assistance or self-pay discounts are available.

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Verdict: Is the Harmony test for you?

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The Harmony prenatal test is a solid choice if you want a reliable, non-invasive way to screen for the most common chromosomal conditions early in pregnancy. But like all NIPTs, it has its limitations.

Here’s a breakdown to help you weigh the pros and cons:

While the Harmony test offers reassurance for certain chromosomal conditions, it doesn’t give you the full picture. Like all NIPTs, it analyzes fetal DNA for specific conditions but doesn’t screen for those that may be passed down from parent to child.

If you're looking for a broader view of your baby’s genetic health — one that includes risks NIPTs can't detect — you might want to consider a parent-based whole-genome carrier screening test like Nucleus.

Get better insight into your baby's genetics with Nucleus

Instead of analyzing your baby’s DNA, Nucleus sequences one parent’s or even both partners’ genomes to identify carrier status for hundreds of inherited conditions. This helps uncover potential risks before they affect your child, especially those that fall outside the scope of NIPTs like Harmony.

Nucleus uses whole-genome sequencing (WGS) to analyze your and your partner’s DNA, providing insights that help you make informed decisions about your baby’s health, whether you’re planning to start a family or are already pregnant.

Here’s how Nucleus can give you a broader picture of your baby’s genetic health:

• Comprehensive carrier screening: Tests you and your partner for risks related to 900+ inherited diseases and conditions, including cystic fibrosis, Tay-Sachs, muscular dystrophy (MD), and many more that aren’t covered by standard prenatal tests.

• At-home convenience with clinical accuracy: You don’t need a doctor’s approval or visits to a clinic to take Nucleus. You can take the test at home and still get results with 99.9% accuracy.

• Clear, easy-to-understand reports: You don’t need to be an expert in genetics to understand your results. Your report will be written in language you can understand, and you’ll receive actionable advice to guide your next steps.

• Expert guidance: In case you want to discuss your results with an expert, Nucleus offers access to genetic counselors who’ll help you understand what your results mean for your family.

• Secure and reliable: Nucleus adheres to strict privacy standards (HIPAA) and lab quality certifications (CAP-CLIA) to protect your data and ensure accuracy.

By focusing on what you may carry rather than your baby’s DNA, Nucleus provides information that helps shape your family planning decisions well before pregnancy milestones.

Get tested with Nucleus

With Nucleus, you can easily test for inherited genetic risks from the comfort of your home. Here's how it works:

1. Sign up for Nucleus

2. Provide your personal information

3. Place your order

When your test kit arrives, swab the inside of your cheeks at home and pop the sample in the prepaid envelope to mail it back. You’ll get your detailed genetic report in about 6–8 weeks.

The kit costs $499 for one person or $798 if both partners get tested — that includes everything you need for sample collection, shipping, and your results.

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