Non-invasive Prenatal Test (NIPT)

Overview

Non-invasive prenatal testing (NIPT) uses cell-free DNA (cfDNA) in mother’s blood to evaluate possible chromosomal conditions in a pregnancy and can be performed as early as 10 weeks of pregnancy using a single blood draw.

Roche offers the Harmony^® prenatal test, with a focused and clinically-relevant menu that screens for trisomy 21, trisomy 18, and trisomy 13. Additional menu options include monosomy X, 22q11.2 microdeletion, other sex chromosome aneuploidies, and fetal sex.

The Harmony test has been used to screen over two million pregnancies¹ and is trusted by patients, clinicians, and labs worldwide. Backed by the commitment and quality of Roche Diagnostics, the Harmony test is an opportunity to maximize your offering in the NIPT market.

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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.

Non-invasive Prenatal Test (NIPT)

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