1 million and counting

For Pregnant Women

The Harmony Prenatal Test is a DNA-based non-invasive prenatal test (also known as a non-invasive prenatal screen “NIPS”) for Down syndrome (trisomy 21), trisomy 18 and trisomy 13. It is proven to be more accurate than traditional screening tests and can be performed as early as 10 weeks of pregnancy.The Harmony Prenatal Test can also report fetal sex, screen for sex chromosome conditions and 22q11.2 deletion.

The greater accuracy and low false-positive rate of Harmony compared to traditional tests may minimize the chance that further testing would be recommended due to a false-positive result.

Talk to your healthcare provider about the benefit of having the Harmony Prenatal Test.

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For Healthcare Providers

Clear ANSWERS to Questions that Matter

The Harmony® Prenatal Test is a cell-free DNA (cfDNA) test that is validated for women of any age or risk*.

Studied extensively in blinded prospective published trials including >22,000 pregnant women.2

Read the results of the first blinded study of its kind in New England Journal of Medicine showing superior performance by Harmony Prenatal Test compared to traditional first trimester screening (LINK to the NEJM study info)1

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For Laboratories

Targeted Technology

Laboratories can implement the Harmony® Prenatal Test with ease.

Flexible options include:

  • Test Send Out samples to the Ariosa Diagnostics Inc., a CLIA-certified CAP-accredited laboratory
  • Ariosa cell-free DNA System (AcfS) and the Harmony CE-IVD Kit with library to results automation.

Test menu includes Trisomy 21, Trisomy 18, Trisomy 13, Fetal Sex, Monosomy X, Sex Chromosome Aneuploidies, and 22q11.2.

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* Both under 35 and over 35 age groups, studies have included women ages 18-48
1. Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97
2. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6

 

For Harmony Kit and AcfS customers

Please contact your local Roche affiliate for support and questions

For customers and healthcare professionals who send patient samples to the Ariosa Diagnostics Inc. laboratory

Ariosa Diagnostics Inc. service and support professionals are available to answer your questions about the Harmony Prenatal Test and provide any assistance that you may require. The Ariosa Diagnostics Client Services team is available to assist you Monday through Friday, 6 am to 5 pm Pacific time.

Ariosa Diagnostics Inc.
5945 Optical Ct.
San Jose, California 95138

Toll-free: 1 855-927-4672
Outside of the U.S.A.: +1 925-854-6246
Fax: 877-927-6151