The Harmony test is run on the Ariosa cell-free DNA System (AcfS). This modular system was designed to streamline DANSR assay and FORTE algorithm–based NIPT, while providing cost-efficient scalability.
AcfS approach and benefits
DANSR assay and FORTE algorithm provide exceptional NIPT sensitivity and specificity1
Modular system design streamlines workflow and scalability
No hidden data storage fees
Maximum hands-free operation with no manual pipetting
User-friendly CE IVD-marked AcfS Software and Concerto provide full automation control and library-to-results sample tracking
Local NIPT reduces wait time and maintains on-site results security
Regions that do not recognize the CE Mark may contact us for further information.
1. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6.
Evaluation of automated cfDNA extraction methods
This evaluation compares the performance of three automated cell-free DNA (cfDNA) extraction platforms (MagNA Pure 24, MagNA Pure 96, and QiaSymphony SP/AS) when used with the Roche Harmony prenatal test. The following white paper provides more information about this study: Evaluation of Automated Cell-Free DNA Extraction Methods with Harmony® prenatal test.
The Harmony Prenatal Test is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis and is considered a prenatal screening test, not a diagnostic test. Harmony does not screen for potential chromosomal or genetic conditions other than those expressly identified in this document. Before making any treatment decisions, all women should discuss their results with their healthcare provider, who can recommend confirmatory, diagnostic testing where appropriate. The Harmony Prenatal Test was developed, and its performance characteristics determined by Ariosa Diagnostics, Inc., a CLIA-certified and CAP-accredited clinical laboratory in San Jose, CA USA. This testing service has not been cleared or approved by the US FDA. The Ariosa cell-free DNA System (AcfS) is only available outside of the US. The Harmony CE-IVD Kit is not available for sale in the United States. HARMONY and HARMONY and Design are trademarks of Ariosa Diagnostics, Inc. in the US.
HARMONY is a trademark of Roche in other countries. DANSR is a trademark of Roche. All other product names and trademarks are the property of their respective owners.