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.**
Combined Harmony Performance Across All Clinical Studies.1-3, 7-13
- Harmony has a less than 0.1% false-positive rate for trisomies 21, 18, and 13.
- This means fewer than 1 in 1000 Harmony tests yields a false-positive result.
- With conventional screening, as many as 1 in 20 women will receive a false-positive result. 4
Greater clarity
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
Clear answers early, reduce follow-ups due to false-positives
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 minimize anxiety and invasive procedures caused by false-positive results.5-6
Any age or risk category ^
- 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 500,000 pregnancies tested worldwide.13
A unique methodology
The 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
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. ACOG Committee on Practice Bulletin No. 77. Obstet Gynecol 2007;109:217-27.
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.