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.1 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.
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
* 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
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 in this document. Before making any treatment decisions, 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 and HARMONY and Design are trademarks of Ariosa Diagnostics, Inc. in the US. HARMONY is a trademark of Roche in other countries. All other trademarks are the property of their respective owners.