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The Harmony® Prenatal Test was developed by Ariosa Diagnostics (San Jose, California, USA). The Harmony® reagents and Ariosa cell-free DNA System (AcfS) software used as part of the Harmony Prenatal Test are CE Marked under the IVD Directive 98/79/EC. Harmony is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis. NIPT is intended for prenatal screening and is not intended to be the sole basis for diagnosis. Harmony test results are intended to be used in conjunction with other clinical and diagnostic results according to professional practice, including confirmatory fetal diagnostic tests, parental evaluation, clinical genetic counseling and counseling, as appropriate. 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.

HARMONY and HARMONY design are trademarks of Ariosa Diagnostics, Inc. in the US. HARMONY is a trademark of Roche in other countries. All other trademarks are the property of their respective owners.

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