Get Harmony

The most proven cell-free DNA-based non-invasive prenatal test (NIPT)1

Contact Information

Ask your pregnancy care provider for the Harmony test. You may also contact our client services team.

Call: 1-855-927-4672 (Toll-Free)
Call: 1-925-854-6246

Email Us

 

 

What is NIPT?

Non-invasive prenatal testing (NIPT) uses cell-free DNA (cfDNA) derived from the pregnancy to evaluate possible chromosomal conditions in a pregnancy. NIPT is a prenatal screening test that can be performed as early as 10 weeks of pregnancy using a single blood draw. Prenatal diagnostic tests such as amniocentesis and CVS diagnose the presence of chromosomal conditions. They are typically performed later in pregnancy and are associated with a small risk of pregnancy loss.

Why screen for chromosomal conditions?

Chromosomal conditions such as Down syndrome can affect management of your pregnancy and delivery in addition to the health of your newborn.

These conditions can happen in any pregnancy- even when there is no family history- because they typically are not inherited. They happen by "chance", and although the chance increases with mother's age, most babies with chromosomal conditions are born to women under 35 years of age. 1

That’s why the American College of Obstetricians and Gynecologists (ACOG) recommends that all pregnant women be offered screening and diagnostic tests for chromosomal conditions.2  And since NIPT is the most sensitive screening option for trisomies 21, 18, and 13, the International Society for Prenatal Diagnosis (ISPD) supports offering NIPT to all pregnant women. 3

Your prenatal screening results can provide you and your doctor with information specific to your pregnancy so you can have more informed conversations about your prenatal care.

References

  1. The California Prenatal Screening Program. March 2009. Provider Handbook 2009.
  2. ACOG Practice Bulletin 163 Obstet Gynecol. 2016 May;127(5):e123-37.
  3. Benn et al. Prenat Diagn 2015; 35: 725–734.

For your baby’s health and your peace of mind

The Harmony® prenatal test is a type of NIPT, which can also be called NIPS (non-invasive prenatal screening). It looks at fragments of your baby’s DNA in your blood to provide accurate information about the likelihood for the most common chromosomal conditions as early as 10 weeks. It can also identify the sex of your baby.

Why screen for chromosomal conditions?

Chromosomal conditions such as Down syndrome can affect management of your pregnancy and delivery in addition to the health of your newborn.

These conditions can happen in any pregnancy- even when there is no family history- because they typically are not inherited. They happen by "chance", and although the chance increases with mother's age, most babies with chromosomal conditions are born to women under 35 years of age. 1

That’s why the American College of Obstetricians and Gynecologists (ACOG) recommends that all pregnant women be offered screening and diagnostic tests for chromosomal conditions.2  And since NIPT is the most sensitive screening option for trisomies 21, 18, and 13, the International Society for Prenatal Diagnosis (ISPD) supports offering NIPT to all pregnant women. 3

Your prenatal screening results can provide you and your doctor with information specific to your pregnancy so you can have more informed conversations about your prenatal care.

References

  1. The California Prenatal Screening Program. March 2009. Provider Handbook 2009.
  2. ACOG Practice Bulletin 163 Obstet Gynecol. 2016 May;127(5):e123-37.
  3. Benn et al. Prenat Diagn 2015; 35: 725–734.

For a range of conditions

Chromosomal conditions can occur in any pregnancy. The Harmony prenatal test screens for the most common ones, including:

  • Trisomy 21 (Down syndrome), trisomy 18 and trisomy 13
  • 22q11.2 microdeletion
  • Monosomy X
  • Sex chromosome aneuploidies (SCA)

For three good reasons

Clear answers to your questions

More accurate than traditional screening2  

Fewer false alarms

Lower false positive rates* than traditional screening tests2 
*Reports a high probability for a condition when it is NOT actually present.  

Proven by clinical evidence.

Evaluated in peer-reviewed publications involving >148,000 pregnancies in women both under and over age 351 

Clear answers to your questions

More accurate than traditional screening2  

Fewer false alarms

Lower false positive rates* than traditional screening tests2 
*Reports a high probability for a condition when it is NOT actually present.  

Proven by clinical evidence.

Evaluated in peer-reviewed publications involving >148,000 pregnancies in women both under and over age 351 

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Personal stories of three moms and their journeys

Melissa’s Personal Story

I am the mother of two children, a daughter and a son. At the age of 40, I became pregnant with my second child, a boy. My husband and I knew from the outset I would choose to undergo a non-invasive prenatal test (NIPT). We had experienced a miscarriage with my first pregnancy, so it was important to be armed with as much information as possible about the health of our baby. We wanted to also be prepared if our baby faced any potential chromosomal conditions.

We were proactive about taking a NIPT and I chose to take the Harmony® Prenatal Test, which I learned from my research, through friends and my doctor, can be done as early as 10 weeks of pregnancy. NIPT seemed like such a better option than other screenings that were available to me previously. The test would provide a more accurate result for Down syndrome than the older screening tests.

I’ve supported friends who had false positives with other prenatal screening methods, so accuracy was important. I had a wonderful experience with the Harmony test. It was easily administered, and we received the results, which came back normal, quickly. I believe that gathering information during one’s pregnancy is important. This screening provided the information we sought.

Barbara’s Personal Story

I am a mother to three beautiful children – two on Earth and one angel who watches over us. 

I became pregnant with my first child in 2011 and, at the time, non-invasive prenatal testing (NIPT) wasn’t available. I remember this clearly as I learned of a possible chromosomal condition in my baby from a routine ultrasound and blood test in my second trimester. My husband and I confirmed through amniocentesis that our unborn daughter, Joan, had trisomy 18.

We learned that trisomy 18 is a rare condition that causes serious differences in development – so serious that most babies with trisomy 18 pass away during birth or shortly afterwards. Our doctor discussed our options with us, and we chose to continue our pregnancy with Joan, knowing the difficult challenges we faced. 

My husband and I have had two more children since Joan’s birth and death. During those pregnancies, we used the Harmony® prenatal test. Given our experience losing our daughter to trisomy 18, we were interested in NIPT for a variety of reasons. 

The NIPT was appealing as it’s a simple blood draw – quick, relatively painless, with no risk to the pregnancy- and it can be done in the first trimester. We knew that if the NIPT result had shown a high likelihood for a chromosomal condition, it would have allowed us more time to prepare for our child's unique needs and the road ahead. 

We also knew that we didn’t want to have invasive testing unless an issue was suspected. In both cases, our Harmony test result showed that our children were unlikely to have three of the most common chromosome conditions: trisomy 21, trisomy 18 and trisomy 13. Having NIPT in the first trimester helped ease our anxiety throughout the last two pregnancies. It helped give us some peace of mind. 

Jean’s Personal Story

I know firsthand how important a noninvasive prenatal test (NIPT) can be in helping parents prepare for their babies. While pregnant with my second son I had standard blood testing with a nuchal translucency ultrasound, and the results showed that my baby had a high chance of being born with Down syndrome. I was very worried, and wanted more information. The follow-up options presented to my husband and me were not satisfying to us.

I found out that the Harmony test has a higher accuracy than the older screening tests, so I asked my doctor for it. I soon received the results, which showed that my baby had a very low chance of having Down syndrome, and other two conditions tested.

I’m happy to report that our little boy is now three-years-old and doing great. I am so glad that I chose to take the Harmony test. Our experience with Harmony NIPT was a positive one. I’m glad I took the initiative to learn more about prenatal screening options and I would encourage other expectant moms to do the same during their first trimester to get early answers.

For your peace of mind

The Harmony test involves just three simple steps.

At 10 weeks or later your blood is drawn.

Your blood sample is sent to a laboratory where it is analyzed.

Your results are sent to your healthcare provider in about seven business days.

At 10 weeks or later your blood is drawn.

Your blood sample is sent to a laboratory where it is analyzed.

Your results are sent to your healthcare provider in about seven business days.

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Questions & Answers

Find answers to your questions. We’re here to provide all the information you need.

Q:How accurate is the Harmony prenatal test?

A:

Using a DNA-based technology, the Harmony prenatal test has been shown to identify more than 99% of pregnancies with Down syndrome.1 By comparison, traditional blood tests can miss as many as 15% of pregnancies with Down syndrome.2

The Harmony prenatal test is also much less likely than traditional tests to give you a false-positive result, meaning there is much less chance your doctor would recommend follow-up invasive testing like amniocentesis.

The Harmony prenatal test is a screening test. Results should be confirmed with diagnostic testing such as amniocentesis and chorionic villus sampling  (CVS). 

Read more about the accuracy of the Harmony prenatal test.

References

  1. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6.
  2. ACOG Practice Bulletin 163 Obstet Gynecol. 127(5):815-816, May 2016

Q:How does the Harmony prenatal test work?

A:

When you are pregnant, your blood contains pieces of DNA from your developing baby. The Harmony prenatal test is a test that analyzes DNA in a sample of your blood to assess the chance of Down syndrome (trisomy 21) and other chromosome conditions called trisomy 18 and trisomy 13.

Q:How is the Harmony prenatal test different from other screening tests for Down syndrome?

A:

The Harmony prenatal test delivers clear answers as early as the first trimester with a single blood draw. Other screening tests for Down syndrome are performed later in pregnancy and require multiple office visits. Traditional 1st trimester serum screening tests are associated with a false-positive rate as high as 5%.2 
The Harmony prenatal test uses a unique method of targeted DNA analysis that, combined with extensive quality controls, achieves over 99% detection rate and a false-positive rate less than 0.1%.1

References

  1. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6.
  2. ACOG Practice Bulletin 163 Obstet Gynecol. 127(5):815-816, May 2016

Q:Can the Harmony prenatal test also evaluate fetal sex, and the X and Y sex chromosomes ?

A:

Yes, the Harmony prenatal test has the option to evaluate sex chromosome aneuploidy (monosomy X, XXX, XXY, XYY and XXYY) and 22q11.2 microdeletion

Q:Should I consider the Harmony prenatal test if I am under 35 years of age?

A:

Yes. Recent professional society guidelines support the offering of non-invasive prenatal testing to the general population. 1-2 The Harmony prenatal test has been extensively validated in women both over and under 35. 3 Most babies with Down syndrome are born to women who are less than 35 years old, even though the chance for Down syndrome in a pregnancy increases with a woman’s age. 4

References

  1. Benn et al. Prenat Diagn. 2015 Aug;35(8):725-34.
  2. Gregg et al. Genet Med. 2016 Oct;18(10):1056-65.
  3. Norton et al. New England J of Medicine. 2015; 372(17):1589-1597.
  4. California Prenatal Screening Program 2009

Q:When can I take the Harmony Test?

A:

As early as 10 weeks into your pregnancy, you can take the Harmony prenatal test with a simple blood draw. 

Q:When can I expect results from the Harmony Prenatal Test?

A:

In seven days or less, your healthcare provider will receive the results and can share them with you.

Q:Where can I find out more about Down syndrome, trisomy 18 and trisomy 13?

A:

You can find more information on trisomy 21, trisomy 18 and trisomy 13 in What We Test For section

Q:I’m expecting twins. Can I take the Harmony prenatal test?

A:

Yes. Harmony prental test can be used in twin pregnancies for trisomies 21, 18 and 13. Sex chromosome aneuploidy and 22q11.2 microdeletion cannot be tested for in twin pregnancies.

Q:I’m expecting a baby through IVF. Can I take the Harmony prenatal test?

A:

Yes. In most cases, the Harmony prenatal test can be used in pregnancies conceived through in vitro fertilization (IVF).

Q:I have another question that is not answered here. Who do I ask?

A:

For questions that relate to your specific case and personal concerns, it’s best to talk to your healthcare provider. A list of Questions for your healthcare provider you can print for your next visit is available.

Q:What does the test report look like?

Get the Harmony test today

Ask your doctor about the Harmony test.





Contact Information


Ask your pregnancy care provider for the Harmony test. You may also contact our client services team.

Call: 1-855-927-4672 (Toll-Free)
Call: 1-925-854-6246

Email Us

 

 

References

  1. Demonstrated by 48 peer-reviewed published studies using the Harmony prenatal test as of January 2018.
  2. Norton et al. New England J of Medicine. 2015; 372(17):1589-1597.

The Harmony Prenatal Test is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis and is considered a prenatal screening test, not a diagnostic test. Harmony does not screen for potential chromosomal or genetic conditions other than those expressly identified here. All women should discuss their results with their healthcare provider, who can recommend confirmatory, diagnostic testing where appropriate. The Harmony Prenatal Test was developed, and its performance characteristics determined by Ariosa Diagnostics, Inc., a CLIA-certified and CAP-accredited clinical laboratory in San Jose, CA USA. This testing service has not been cleared or approved by the US FDA.

HARMONY is a trademark of Roche. All other product names and trademarks are the property of their respective owners.

 

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