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Harmony Prenatal Test LogoA higher standard in cell-free DNA testing.

Studied in over 6,000 patients, including >2,000 average-risk women1-7

 
Detection Rate
False Positive Rate
T21  
 
>99%
(231 of 232)
<0.1%
T18  
 
>98%
(103 of 105)
<0.1%
T13  
8 of 10 <0.1%

X and Y analysis is >99% accurate for fetal sex. It can also assess risk for sex chromosome conditions with test performance varying by the type of condition detected.7


Dependable accuracy as early as 10 weeks’ gestation

Directed cfDNA technology for detection of trisomies 21, 18 and 13 has been studied in over 6,000 patients:

  1. Sparks, A.B., Wang, E.T., Struble, C.A., Barrett, W., et al, Selective analysis of cell-free DNA in maternal blood for evaluation of fetal trisomy. Prenat Diagn (2012);32(1):3-9. doi: 10.1002/pd.2922. Epub 2012 Jan 6.
  2. Sparks, A.B., Struble, C.A., Wang, E.T., Song, K., Oliphant, A., Non-invasive Prenatal Detection and Selective Analysis of Cell-free DNA Obtained from Maternal Blood: Evaluation for Trisomy 21 and Trisomy 18, Am J Obstet Gynecol. (2012), doi: 10.1016/j.ajog.2012.01.030.
  3. Ashoor, G., Syngelaki, A., Wagner, M., Birdir, C., Nicolaides, K.H., Chromosome-selective sequencing of maternal plasma cell-free DNA for first trimester detection of trisomy 21 and trisomy 18, Am J Obstet Gynecol. (2012), doi: 10.1016/j.ajog.2012.01.029.
  4. Norton, M., Brar, H., Weiss, J., Karimi, A., et al. Non-Invasive Chromosomal Evaluation (NICE) Study: Results of a Multicenter, Prospective, Cohort Study for Detection of Fetal Trisomy 21 and Trisomy 18, Am J Obstet Gynecol. (2012), doi:10.1016/j.ajog.2012.05.021.
  5. Nicolaides KH, Syngelaki A, Ashoor G, et al. Noninvasive prenatal testing for fetal trisomies in a routinely screened first-trimester population.Am J Obstet Gynecol 2012;207:374.e1-6.
  6. Ashoor, G., Syngelaki, A., Nicolaides, K.H., et al. Trisomy 13 detection in the first trimester of pregnancy using a chromosome-selective cell-free DNA analysis method, ULTRASOUND Obstet Gynecol. (2012), DOI: 10.1002/uog.12299.
  7. Data on file.