Non-Invasive Prenatal Test (NIPT)

Non-Invasive Prenatal Test (NIPT)

The Harmony® prenatal test from Roche is a cell-free DNA (cfDNA)-based non-invasive prenatal test (NIPT) or non-invasive prenatal screening (NIPS) that enables screening for specific chromosome conditions in a pregnancy as early as in 10 weeks of gestation. NIPT is a growth opportunity you can pursue with a partnership that allows you to choose the adoption method most appropriate for your lab.

Proven accuracy. Trusted quality. Focused technology

When it comes to delivering consistently high-quality results for non-invasive prenatal testing, the Harmony prenatal test is your answer. The Harmony test, a validated and extensively-studied NIPT, is trusted by labs and clinicians worldwide and has been used to screen more than one million pregnancies.* Backed by the commitment and quality of Roche Diagnostics, the Harmony test is your opportunity to maximize your offering in the NIPT market.

Inspire confidence with clearer answers

Healthcare providers and patients count on your lab to provide the clarity they need with confidence. The Harmony test:

  • Offers a focused and clinically-relevant menu. Screens for trisomy 21, trisomy 18 and trisomy 13, which keeps the false positive rates low. Additional menu options include monosomy X and other sex chromosome aneuploidies, 22q11.2 microdeletion and fetal sex.
  • Provides reliable information with fewer false alarms. The Harmony test has a 90-fold lower false positive rate than traditional first trimester screening.False positive results increase patient anxiety, complexity of counseling and unnecessary invasive procedures.
  • Incorporates and reports fetal fraction, an important quality metric for NIPT,2,3 and provides a personalized probability score for each patient. Results from cfDNA-based prenatal tests that do not require a minimum threshold of fetal fraction may be based solely on maternal DNA.4 The Harmony test results are based on demonstrated accurate fetal fraction evaluation.5

Deliver consistently accurate and reliable results

The reputation of your lab depends on the accuracy and reliability of the results you provide. The Harmony test has stringent quality metrics and is the most proven NIPT on the market with industry-leading performance for trisomy 21, 18, and 13.6

*Data on file.

REFERENCES

  1. Norton et al. New England J of Medicine. 2015; 372(17):1589-1597.
  2. Benn et al. Prenat Diagn 2015; 35: 725-734.
  3. Gregg et al. Genetics in Medicine 2016 Oct; 18(10):1056-65.
  4. Takoudes and Hamar. Ultrasound ObstetGynecol 2015;14:112-116.
  5. Schmid et al. Ultrasound Obstet Gynecol. 2018 Jun;51(6):813-817.
  6. Stokowski et al. Prenatal Diagn. 2015; 35:1243-1246.