Harmony Prenatal Test

Clear answers to questions that matter

The Harmony® Prenatal Test is a blood screening test, validated for pregnant women of any age or risk category. As early as 10 weeks of pregnancy, the Harmony® Prenatal Test screens for the risk of trisomy 21 (Down Syndrome), 18 and 13.**

 

  • Harmony has a less than 0.1% false-positive rate for trisomies 21, 18, and 13.1-3, 7-13
  • This means fewer than 1 in 1000 Harmony tests yields a false-positive result.1-3, 7-13
  • With conventional screening, as many as 1 in 20 women will receive a false-positive result.4

The Harmony Prenatal Test evaluates the probability of trisomies 21, 18 and 13 with unsurpassed accuracy in women of any age or risk category2. Studies have shown that if there is <4% fetal fraction in the maternal blood sample, the ability of any NIPT test to detect trisomy will suffer.14,15 As part of our commitment to quality, the Harmony test will not report a result if the fetal fraction is below 4% reducing the chance of an inaccurate result.

The Harmony Prenatal Test has a high level of accuracy, bringing clarity to genetic testing for common trisomies.

  • In blinded clinical trials, Harmony correctly identified over 99% of cases of trisomy 21.1-2
  • Conventional screening tests can miss 15% or more of trisomy 21 cases.4

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 compared to traditional tests may minimise anxiety and invasive procedures caused by false-positive results.5-6

 

  • Harmony Prenatal Test is clinically validated for use in pregnant women, of any age or risk category, to assess the risk of fetal trisomies 21, 18 and 13.1-3
  • Studied extensively in blinded prospective trials including more than 22,000 women of all ages.1-2, 8-9, 11
  • Over 1,000,000 pregnancies tested worldwide.13

Harmony uses a targeted technological approach to DNA assessment – focusing on analysing only the specific chromosomes of interest and the precise measurement of fetal DNA using SNPs (single nucleotide polymorphisms) to achieve greater accuracy.7

 

 

For further information please email australia.harmony@roche.com or visit our website at www.harmonytest.com

 

References

**Harmony is designed to assess risk for trisomy 21, 18, and 13 and sex chromosome aneuploidy. It cannot exclude all genetic defects nor detect every problem that may occur in pregnancy.
^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. Norton et al. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8.
3. Ashoor et al. Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5.
4. RANZCOG/HGSA Committee on Prenatal Diagnosis and Screening. Guideline C-Obs59. 2015 Mar.
5. Wax et al. J Clin Ultrasound. 2015 Jan;43(1):1-6.
6. Lou et al. Acta Obstet Gynecol Scand. 2015;94(1):15-27.
7. Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.
8. Verweij et al. Prenat Diagn. 2013 Oct;33(10):996-1001.
9. Nicolaides et al. Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6.
10. Ashoor et al. Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.
11. Gil et al. Fetal Diagn Ther. 2014;35:204-11.
12. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.
13. Data on file.
14. Sparks et al. Am J ObstetGynecol. 2012; doi: 10.1016/j.ajog.2012.01.030
15. Canicket al. PrenatDiagn. 2013; doi:10.1002/pd.4126

 

Non-invasive prenatal testing (NIPT) based on cell-free analysis is not diagnostic: results should be confirmed by diagnostic testing. 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 is developed by Ariosa Diagnostics. The Harmony Prenatal Test is performed in Australia.

© 2017 Roche Diagnostics. HARMONY PRENATAL TEST and HARMONY are trademarks or registered trademarks of Ariosa Diagnostics, Inc. in the U.S.A. and other countries. All other trademarks are the property of their respective owners.Roche Diagnostics Pty Ltd. 2 Julius Avenue, North Ryde NSW 2113 ABN 29 003 001 205