To date, cell-free DNA (cfDNA) screening for fetal trisomy has been offered primarily to women at increased risk for fetal aneuploidy, but not to the general pregnancy population. Recently, the results of a large, prospective, multicenter, blinded study were published, demonstrating that the Harmony test for risk assessment of trisomy 21 (Down Syndrome) outperforms combined first trimester screening in the general pregnancy population. This supplement examines the crucial findings of cfDNA analysis for Down syndrome screening in the general pregnancy population using the Harmony test.
The Harmony Prenatal Test is developed by Ariosa Diagnostics. Ariosa Diagnostics is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies. Non-invasive prenatal testing (NIPT) services based on cell-free DNA analyses are not diagnostic; high-risk results should be confirmed by diagnostic testing. Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.
To view an exclusive video on the pivotal findings discussed in this supplement, click here.