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Roche’s Harmony prenatal test wins CE mark approval

MDBR Staff Writer Published 03 October 2016

Roche has secured CE mark approval for its Harmony prenatal test to assess the probability of Down syndrome (Trisomy 21) and other chromosomal disorders.

The CE-IVD Harmony renatal test, which is based on cell-free DNA analysis, is a non-invasive prenatal test (NIPT) for pregnant women.

The test evaluates the probability of Trisomy 21 and other common fetal aneuploidies by assessing fetal cell-free DNA found in maternal blood, including accurate measurement of the fetal fraction of DNA.

According to the company, the results are intended for prenatal screening and are not intended to be the sole basis for diagnosis.

In 2012, the company initially launched Harmony as a send-out test designed to assess the probability of fetal trisomy 21, 18, 13, and sex chromosome aneuploidy.

Currently, the firm is offering micro-array based Harmony IVD kit and Ariosa Cell-Free DNA System (AcfS) software to laboratories for conducting non-invasive prenatal testing.

The company intends to make the Harmony IVD kit available to customers by the end of this year.

Roche sequencing solutions head Neil Gunn said: "We are pleased to introduce even greater access to the Harmony Prenatal Test to local laboratories, obstetricians, and expectant parents.

"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."