The Harmony Prenatal Test is a cell-free DNA based technology or non-invasive prenatal test (NIPT) that provides an assessment for the probability of fetal triso-mies 21 (Down syndrome), 18, and 13. The test can also screen for sex chromosome (X, Y) aneuploidies and fetal sex. This screening test can be performed starting at 10 weeks gestation.
The Harmony Prenatal Test is available to laboratories around the world via the Ario-sa cell-free DNA System (AcfS) or as a test send out service (TSO).
Ariosa cell-free DNA System (AcfS)*
Non-Invasive Prenatal Testing Performed in your Laboratory
The AcfS is a modular, microarray-based, system designed to streamline the Harmo-ny (DANSR/FORTE) prenatal test for de-centralized testing at local laboratories. AcfS is optimized for laboratories perform-ing 400 or more NIPTs per month and can easily scale to accommodate tens of thou-sands of tests per year. The Harmony re-agent kit for the AcfS system is available in CE-IVD and RUO versions.*
Harmony Prenatal Test as Test Send Out service (TSO)
Laboratories and physicians can offer the Harmony Prenatal Test by sending whole blood specimen directly to the CLIA and CAP accredited laboratory located in San Jose, CA USA.
The Harmony Prenatal Test is Validated for Pregnant Women of Any Age or Risk** and Trusted by Clinicians Worldwide
Technology benefit of the directed analysis (DANSR), Individualized Assessment (FORTE)
DANSR assay allows for deeper analysis by focusing on the specific chromosomes of interest, rather than random, whole
FORTE algorithm measures, incorporates, and reports fetal fraction for every sample. Incorporation of maternal and gestational age provides for an individualized result as opposed to an arbitrary positive/negative value.
Greater Efficiency at Lower Cost
The Harmony test second generation cus-tom microarray technology improves the precision and throughput of DANSR/FORTE3, while reducing time-to-result, overall labor, and reportable results costs.
*Not available in all markets
**Both under 35 and over 35 age groups, studies have included women ages 18-48
Workflow and Scalability
Integrated User Interface
Security and Transparency