Understanding the importance of fetal fraction as a quality metric for accurate results.
Best Practices in Non-Invasive Prenatal Testing
June 20, 2017
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.