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.5 Microarray technology further enhances performance, speed, and efficiency.5
- 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
FORTE Algorithm Incorporates Accurate Measurement of Fetal DNA, Maternal Age, and Gestational Age
• Clearly distinguishes high-risk and low-risk results7
• Outperforms the Z-statistic approach7
- Sparks et al. Prenat Diagn. 2012 Jan;32(1):3-9.
- Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.
- Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.
- Rava et al. Clin Chem. 2014 Jan;60(1):243-50.
- Jensen et al. PLoS One. 2013;8(3):e57381.
- Data on file.
- Ashoor G et al., Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.