Dr. Ron Wapner presents the results of the Harmony NEXT Study. The study was published in the New England Journal of Medicine, April 2015.
Read published, peer-reviewed studies on Harmony’s clinical performance and the importance of fetal fraction.
|Published NIPT Studies|
|Cell-free DNA analysis for Non-invasive Examination of Trisomy (NEXT) (Read Study)||15,841||N Engl J Med. 2015 Apr 1. [Epub ahead of print] DOI: 10.1056/NEJMoa1407349|
|NICE-Cohort Validation Study (Read Study)||3,228||Norton et al. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8.|
|General Screening Population, 1st Trimester (Read Study)||2,049||Nicolaides et al. Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6.|
|Trisomy 13 (Read Study)||1,949||Ashoor et al. Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5.|
|Kypros Nicolaides Clinical Implementation (Read Study)||1,005||Gil et al. Ultrasound Obstet Gynecol. 2013 Jul;42(1):34-40.|
|High-Risk Population, 1st Trimester (Read Study)||400||Ashoor et al. Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.|
|FORTE (Read Study)||338||Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.|
|DANSR (Read Study)||298||Sparks et al. Prenat Diagn. 2012 Jan;32(1):3-9.|
|Ob/Gyn Real World Experience (Read Study)||289||Fairbrother et al. Prenat Diagn. 2013 Jun;33(6):580-3.|
|Twins Study (Read Study)||275||Mar Gil et al. Fetal Diagn Ther. 2014;35:204-11.|
|Sex Chromosome Aneuploidies (Read Study)||275||Mar Gil et al. Fetal Diagn Ther. 2014;35:204-11.|
|Sex Chromosome Aneuploidies (Read Study)||432||Hooks et al. Prenat Diagn. 2014 May;34(5):496-9.|
|Microarray-Based Cell-Free DNA Analysis (Read Study)||878||Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6|
|Clinical Performance with Microarrays or Next Generation Sequencing (NGS) is Consistent Across Multiple Controlled Clinical Studies (Read Study)||Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686|
|Maternal Weight Effects–Commercial Data (Read Study)||22,000||Wang et al. Prenat Diagn. 2013 Jul;33(7):662-6.|
|Consistent in High and Low-Risk Women (Read Study)||3,007||Brar et al. J Matern Fetal Neonatal Med. 2013 Jan;26(2):143-5.|
|Maternal Weight and Fetal Factors, Study 2 (Read Study)||1,949||Ashoor et al. Ultraound Obstet Gynecol. 2013 Jan;41(1):26-32.|
|Fetal Fraction in Twins (Read Study)||70||Struble et al., Fetal Diagn Ther. 2014;35:199-203.|
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.