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The Harmony Prenatal Test is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis and is considered a prenatal screening test, not a diagnostic test. 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. The Harmony Prenatal Test was developed, and its performance characteristics determined by Ariosa Diagnostics, Inc., a CLIA-certified and CAP-accredited clinical laboratory in San Jose, CA USA. This testing service has not been cleared or approved by the US FDA. The Ariosa cell-free DNA System (AcfS) is only available outside of the US. The Harmony CE-IVD Kit is not available for sale in the United States.
HARMONY is a trademark of Roche in other countries. All other trademarks are the property of their respective owners.