Videos

Best Practices in Non-Invasive Prenatal Testing

Best Practices in Non-Invasive Prenatal Testing

Best Practices in Non-Invasive Prenatal Testing
June 20, 2017
Ashley Allen

NEXT Study Overview and Results with Dr. Ron Wapner

NEXT Study Overview and Results with Dr. Ron Wapner

Dr. Ron Wapner presents the results of the Harmony NEXT Study. The study was published in the New England Journal of Medicine, April 2015.

Harmony Prenatal Test Patient Education Video

Harmony Prenatal Test Patient Education Video

This video provides expecting parents information on some of the genetic conditions that may affect a pregnancy with an overview of tests available for these conditions.

Published Studies

Read published, peer-reviewed studies on Harmony’s clinical performance and the importance of fetal fraction.

Study Subjects Reference
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
Fetal Fraction
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.
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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.