Exceptional Performance

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

Learn more about Harmony Test performance

Greater clarity

Harmony Prenatal Test has exceptional accuracy, bringing clarity to genetic testing for common trisomies. 

● In blinded clinical trials, the Harmony test correctly identified over 99% of cases of trisomy 211-2

● Conventional screening tests can miss 15% or more of trisomy 21 cases4

Any age or risk category

The 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 ages1-2,8-9,11

● Over 1,000,000 pregnancies tested worldwide14

Both under 35 and over 35 age groups, studies have included women ages 18-48

Learn more about Harmony Clinical Data

A unique methodology

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

Learn more about the Harmony Test’s Technology

 

References

†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.

  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. 163. Obstet Gynecol. 2016 May;127(5):e123-37
  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. Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686.
  14. Data on file.