A Proprietary, Targeted Technology

During pregnancy, cfDNA fragments of the mother and the fetus circulate in the mother’s blood. Harmony targets fetal DNA with its proprietary technology, DANSR™ and FORTE™. This targeted approach yields a deeper analysis of the chromosomes of interest (e.g. 21, 18, 13) versus massively parallel shotgun sequencing.1-3

Our unique method of targeted DNA analysis achieves a combined accuracy greater than 99% and a combined false-positive rate less than 0.1% for trisomy 21.4 We infuse the best of SNP technology with a microarray platform, so clinicians get an analysis deeper than random sequencing. Our SNP analysis distinguishes maternal from fetal DNA and quantifies the fetal fraction. It’s coupled with DANSR™, a unique and targeted approach focusing only on cfDNA from the chromosomes of interest. Harmony incorporates the fetal DNA measurement into its probability assessment using FORTE™, a proprietary algorithm, to more clearly distinguish high and low-probability results.1-3

Fetal DNA measurements are incorporated into the FORTE algorithm, which also incorporates maternal risk factors and precise fetal fraction allowing Harmony to provide individual probability scores for each patient.2-3

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. Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686

The Harmony Prenatal Test was developed by Ariosa Diagnostics, a CLIA-certified laboratory. As with other lab-developed tests, it has not been cleared or approved by the FDA and is not available for sale as an IVD in the US. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

PP-US-06564