NEXT is now: Landmark study demonstrates superiority

In the New England Journal of Medicine’s NEXT (Non-Invasive Examination of Trisomy) Study — the largest blinded study of its kind — the Harmony Non-Invasive Prenatal Test was compared to First Trimester Combined Screening (FTS**). The results found that Harmony testing for trisomy 21 had a higher detection rate, a lower false positive rate, and a higher positive predictive value. In the landmark NEXT Study, Harmony had a 100% trisomy 21 detection rate compared to a 79% detection rate with FTS**.1

NEXT Study Design

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Harmony demonstrates exceptional detection

When looking at the total number of blinded prospective published studies to date using Harmony, over 22,000 pregnant women have been studied. In each of these studies Harmony demonstrated exceptional detection and false-positive rates.1-5

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22q11.2, the Most Common Microdeletion

The 22q11.2 deletion syndrome is the most common microdeletion, and affects as many as 1 in 1,000 to 1 in 2,500 pregnancies.  22q11.2 deletion syndrome, also referred to as DiGeorge syndrome or Velo-Cardio-Facial syndrome, is caused by a missing piece of genetic information from chromosome number 22. It is almost as common as Down syndrome and more common than cystic fibrosis.11- 15

22q11.2 deletion syndrome can affect nearly all parts of the body. Nearly 75% of babies with 22q11.2 deletion syndrome have heart defects.  Other common symptoms include cleft palate, kidney problems, immune system weakness, learning disabilities, and behavioral disorders, such as autism and schizophrenia.11, 12

Understanding the risk for 22q11.2 deletion syndrome early can help guide decisions during pregnancy and after the birth of your baby.

Note: 22q11.2 is not available to women that are known to have this deletion.

*Both under 35 and over 35 age groups, studies have included women ages 18-48
**Serum PAPP-A, total or free ß-hCG & Nuchal Translucency

References: 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. Verweij et al. Prenat Diagn. 2013 Oct;33(10):996-1001. 4. Nicolaides et al. Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6. 5. Gil et al. Fetal Diagn Ther. 2014;35:204-11. 6. Ashoor et al. Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5. 7. Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9. 8. Ashoor et al. Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5. 9. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6. 10. Data on file at Ariosa Diagnostics. 11. “Microdeletion syndrome”. Genetics Home Reference. April 17, 2014. Accessed 2/7/16 12. Bassett et al. J Pediatr. 2011 Aug;159(2):332-9 13. McDonald-McGinn et al. Genet Med. 2001 Jan-Feb; 4. (1):23-9. 14. McDonald-McGinn, et al. (2015). 22q11.2 deletion syndrome. Nature Reviews Disease Primers. 15. NIH Genetics Home Reference https://ghr.nlm.nih.gov/condition/cystic-fibrosis#statistics

The Harmony Prenatal Test was developed by Ariosa Diagnostics, a CLIA-certified laboratory. As with other lab-developed tests, it has not been cleared or approved by the FDA and is not available for sale as an IVD in the US. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

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