Non-Invasive Prenatal Test (NIPT)

Implementing the Harmony® prenatal test in your laboratory

Since 2012 the Harmony prenatal test has been ordered for more than 1.4 million women and is trusted by healthcare providers in more than 100 countries.1

The Harmony prenatal test (Harmony test) provides an individualized assessment for the most common fetal aneuploidies. Its proprietary DANSR assay and FORTE algorithm have been studied extensively with consistently superior results in both high-risk and average-risk populations.2-3

The Harmony test consists of the CE-marked Harmony IVD Kit, AcfS Software (which includes the FORTE algorithm), and a set of required equipment including the Concerto Imager IVD. 

Harmony Test Menu

  • Trisomy 21 (Down syndrome)
  • Trisomy 18
  • Trisomy 13


Additional Test Options

  • Fetal Sex
  • Monosomy X*
  • Sex Chromosome Aneuploidies*
  • 22q11.2 deletion*

*singleton pregnancies only


Validated Patient Populations

  • Singleton Pregnancies
  • Twin Pregnancies
  • IVF Pregnancies 
    • self and non-self egg donors
  • In both average and high risk population (women under and over age 35)


Clinical Performance

The Harmony test is the most broadly studied cell-free DNA test with greater than 148,000 women studied in 48 peer-reviewed publications.4

References

  1. Data on file, available in more than 100 countries. More than 1,400,000 tests performed.
  2. Norton et al. N Engl J Med. 2015. Apr 23,372(17):1589-97.
  3. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6.
  4. Demonstrated by 48 peer-reviewed published studies using the Harmony prenatal test as of Jan 2018. For the entire 48 references, please go to harmonytest.com/references