© 2019 F. Hoffmann-La Roche Ltd
*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; 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.