The Harmony Prenatal Test is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis. Harmony does not screen for potential chromosomal or genetic conditions other than those expressly identified here. The results are intended for prenatal screening and are not intended to be the sole basis for diagnosis. Harmony test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmatory fetal diagnostic testing, parental evaluation, clinical genetic evaluation, and counseling, as appropriate. This test is offered as a CE-IVD.* This test has not been cleared or approved by the US FDA.

*Note: Because the fetal sex determination test option does not have a medical purpose, it does not meet the definition of an IVD device and therefore is not a CE marked product.

HARMONY is a trademark of Roche. All other product names and trademarks are the property of their respective owners.