Harmony Prenatal Test

Harmony Prenatal Test

Clear ANSWERS to question that matter

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.

 

Your benefit


Clinical Benefit
The Harmony Prenatal Test is Validated for Pregnant Women of Any Age or Risk** and Trusted by Clinicians Worldwide

  • Studied extensively in blinded prospective trials1
  • Harmony Test significantly outperformed First Trimester Combined Screening (FTS**) in both trisomy 21 detection and false-positive rate in a blinded, prospec-tive head-to-head comparison2


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 
 genome sequencing. 


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 

 

Ariosa cell-free DNA System: Features and Benefits


Operational Efficiency

  • Maximum hands-free operation
  • No manual pipetting


Workflow and Scalability

  • Custom microarray technology and rapid quantification streamlines workflow
  • Modular AcfS allows for cost-efficient system expansion as needed


Integrated User Interface

  • User-friendly Director interface provides full process automation control
  • Director ensures accurate library-to-re-sults sample tracking for optimal control


Security and Transparency

  • Patient data housed on local server to avoid exposure on the cloud
  • Complete price clarity: no hidden fees or unexpected requirements

 

 

  1. Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686
  2. Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97.
  3. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.