The Harmony® Prenatal Test is validated for pregnant women of any age or risk category* and trusted by clinicians worldwide.
AS EARLY AS 10 WEEKS, the Harmony test screens for trisomies 21, 18, and 13.
Clear answers early, reduce follow-ups due to false-positives
The Harmony Prenatal Test helps healthcare professionals give expectant parents accurate information** about common fetal aneuploidies.1-4 Conventional prenatal screening methods using serum proteins and ultrasound have higher false-positive rates compared to the Harmony Prenatal Test.1-4 The low false-positive rate of Harmony test compared to traditional tests may minimize anxiety and invasive procedures caused by false-positive results.5-6
Combined Harmony test Performance across All Clinical Studies 1-3, 7-13
● The Harmony test has a less than 0.1% false-positive rate for trisomies 21, 18, and 131-3, 7-13
● Fewer than 1 in 1000 Harmony tests yield a false-positive result1-3, 7-13
● With conventional screening, as many as 1 in 20 women will receive a false-positive result 4
The Harmony Prenatal Test uses a targeted technological approach to DNA assessment—focusing on analyzing only the specific chromosomes of interest and the precise determination of fetal fraction to achieve greater accuracy.7
†Both under 35 and over 35 age groups, studies have included women ages 18-48
**Harmony Prenatal Test is designed to screen for trisomy 21, 18, and 13, sex chromosome aneuploidy and 22q11.2 deletion. It cannot exclude all genetic defects nor detect every problem that may occur in pregnancy.
Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97.
Norton et al. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8.
Ashoor et al. Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5.
ACOG Committee on Practice Bulletin No. 163. Obstet Gynecol. 2016 May;127(5):e123-37
Wax et al. J Clin Ultrasound. 2015 Jan;43(1):1-6.
Lou et al. Acta Obstet Gynecol Scand. 2015;94(1):15-27.
Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.
Verweij et al. Prenat Diagn. 2013 Oct;33(10):996-1001.
Nicolaides et al. Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6.
Ashoor et al. Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.
Gil et al. Fetal Diagn Ther. 2014;35:204-11.
Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.
Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686.
Data on file.
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.