Exceptional Performance

A proprietary DNA-based methodology

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

● During pregnancy, cell-free DNA—short DNA fragments—of the mother and the fetus circulate in maternal blood

● The Harmony test analyzes fragments from specific chromosomes, rather than all chromosomes1-2

● 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 

 

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.5 Microarray technology further enhances performance, speed, and efficiency.3

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
Robust microarray quantitation enhances the success rate: 99% of eligible samples return a result.5

Accurate Determination of Fetal Fraction

  • FORTE accurately distinguishes between high and low probability results even at low fetal fraction 2,3
  • Incorporates maternal risk factors and precise fetal fraction determination2,3
  • Individual probability scores provided for each patient

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

FORTE Advantage

  • Clearly distinguishes high-risk and low-risk results4
  • Outperforms the Z-statistic approach4

References

  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. Ashoor G et al., Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.
  5. Data on file.