Initially introduced in 2012 as a send-out test designed to assess the probability of fetal trisomy 21, 18, 13, and sex chromosome aneuploidy, the second-generation Harmony Prenatal Test has improved performance while reducing costs and processing time1. Roche now offers the micro-array based Harmony IVD kit and Ariosa Cell-Free DNA System (AcfS) software to laboratories outside the US in response to the growing demand for local non-invasive prenatal testing.
"We are pleased to introduce even greater access to the Harmony Prenatal Test to local laboratories, obstetricians, and expectant parents," said Neil Gunn, Head of Roche Sequencing Solutions. "Driven by increasing demand and expanded adoption, availability of the Harmony Prenatal Test is backed by the commitment of Roche, the world leader in in vitro diagnostics, making Harmony well positioned to lead the expanding market in decentralized NIPT testing worldwide."
The Harmony IVD kit will be available for shipping by the end of 2016.
1Juneau et al. Fetal Diag Ther. 2014;36(4):282-6. Stokowski et al. Prenatal Diagnosis 2015; 35, 1-4.
About the Harmony Prenatal Test
The CE-IVD Harmony® Prenatal Test is a non-invasive prenatal test (NIPT) for pregnant women, based on cell-free DNA analysis. This blood screening test can be used as early as ten weeks into pregnancy. By evaluating fetal cell-free DNA found in maternal blood, including accurate measurement of the fetal fraction of DNA, the test assesses the probability of Trisomy 21 (Down syndrome) and other common fetal aneuploidies. The results are intended for prenatal screening and are not intended to be the sole basis for diagnosis. 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 originally developed as a laboratory developed test send-out and was validated by a robust clinical data set, and supported by clinical studies in more than 23,000 women ranging from 18-48 years of age in all risk categories. The Harmony Prenatal Test has been used to guide clinical care in over 850,000 pregnancies worldwide as a send-out test or locally performed test using RUO reagents ex-US. For more information, visit www.harmonytest.com.
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