Technology That Drives Results

Technology That Drives Results

The accuracy of the Harmony Prenatal Test rests on a proprietary targeted methodology and careful measurement of fetal DNA.1-2


A proprietary DNA-based methodology

Harmony Prenatal Test relies on a proprietary targeted DNA-based technology (DANSRTM and FORTETM) to provide exceptionally accurate results. 

  • During pregnancy, cell-free DNA—short DNA fragments—of the mother and the fetus circulate in maternal blood
  • Harmony analyzes fragments from specific chromosomes, rather than all chromosomes 1-2
  • SNPs analysis distinguishes maternal from fetal DNA and quantifies the fetal DNA 2-3
  • Targeted analysis results in higher throughput and accurate trisomy risk assessment 3



DANSR Targeted Approach for Deeper Analysis vs Random Sequencing  

In contrast to tests that randomly sequence all cell-free DNA (cfDNA), the Harmony test focuses on cfDNA from the chromosomes of interest.1 This unique, directed approach allows deeper analysis and ultimately yields more accurate results. 1,3-5


Custom Microarray Quantifies DANSR Products with Speed and Accuracy

Microarray technology is a well-established method of quantification also used in prenatal genetic diagnostic applications. Harmony Prenatal Test is a screening test and is able utilize microarray technology due to its proprietary targeted approach.Microarray technology further enhances performance, speed, and efficiency.5

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  • Significant time savings are realized with microarray versus sequencing; laboratory turnaround time is as soon as 3 days, most in 5 days after sample receipt
  • Test success is further enhanced with the highly robust microarray quantification from the already high rates: 99% of eligible samples return a result.6


Accurate Measurement of Fetal Fraction

  • FORTE accurately distinguishes between high and low risk results even at low fetal fraction 2,3
  • Incorporates maternal risk factors and precise fetal DNA measurements2,3
  • Individual risk scores provided for each patient

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FORTE Algorithm Incorporates Accurate Measurement of Fetal DNA, Maternal Age, and Gestational Age




FORTE Advantage

• Clearly distinguishes high-risk and low-risk results7
• Outperforms the Z-statistic approach7

  1. Sparks et al. Prenat Diagn. 2012 Jan;32(1):3-9.
  2. Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.
  3. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.
  4. Rava et al. Clin Chem. 2014 Jan;60(1):243-50.
  5. Jensen et al. PLoS One. 2013;8(3):e57381.
  6. Data on file.
  7. Ashoor G et al., Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.