Harmony® prenatal test
The Harmony prenatal test is a cell-free DNA based test and is considered a prenatal screening test, not a diagnostic test. The Harmony test does not screen for potential chromosomal or genetic conditions other than those expressly identified in this document.
All women should discuss their results with their healthcare provider, who can recommend confirmatory, diagnostic testing where appropriate.
The Harmony IVD Kit (inclusive of Annex II, list B for trisomy 21) is CE marked under the IVD Directive 98/79/EC.
The Ariosa cell-free DNA System (AcfS) is available in select markets. AcfS is designed for use with DANSR, FORTE, and the Harmony Kit. The AcfS Software, and the Concerto, Imager IVD, are CE Marked under the IVD Directive 98/79/EC.