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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.

A proprietary DNA-based methodology

Harmony Prenatal Test relies on a proprietary targeted DNA-based technology 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
  • Targeted analysis results in higher throughput and accurate trisomy risk assessment
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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. This unique, directed approach allows deeper analysis and ultimately yields more accurate results.

 

 

 

Custom Microarray Quantifies DANSR Products with Speed and Accuracy

Microarray technology is a well-established method of quantification and is the standard in prenatal genetic diagnostic applications. The DANSR assay, unlike sequencing approaches, is uniquely able to leverage microarray for the Harmony test due to its targeted nature.

                     

                                                      

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

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Importance of fetal fraction

The Harmony methodology incorporates extensive quality controls:

  • Single nucleotide polymorphism (SNP) analysis is used to precisely quantify cfDNA and determine the fetal DNA contribution in a sample
  • Harmony also incorporates the fetal DNA measurement into its risk assessment using FORTE, a proprietary algorithm, to more clearly distinguish high and low risk results

 

 

Fetal fraction assessment is particularly important at low fetal fractions, where other methodologies have demonstrated a larger number of discordant results.

These important controls are not included at all in some cfDNA-based trisomy tests, increasing the risk of both false-positive and false-negative results.

 

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

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FORTE Advantage

• Clearly distinguishes high-risk and low-risk results
• Outperforms the Z-statistic approach regardless of the subject’s age or risk