Roche has received CE Mark approval for its Harmony Prenatal Test for assessing the probability of Down’s syndrome (Trisomy 21) and other chromosomal disorders.
The Harmony Prenatal Test has been designed as a non-invasive prenatal test (NIPT) option for pregnant women, based on cell-free DNA analysis.
The blood screening test has to be used ten weeks into pregnancy.
The test is intended to identify the probability of Trisomy 21 (Down’s syndrome) and other common fetal aneuploidies by examining the fetal cell-free DNA found in maternal blood, including accurate measurement of the fetal fraction of DNA.
The Harmony Prenatal Test was initially launched in 2012 as a send-out test developed to identify the probability of fetal trisomy 21, 18, 13, and sex chromosome aneuploidy.
The second generation test now features an improved performance with reduced cost and lesser processing time.
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 decentralised NIPT testing worldwide.”
Roche is also offering the micro-array based Harmony IVD kit and Ariosa Cell-Free DNA System (AcfS) software to laboratories outside the US to serve the growing demand for local non-invasive prenatal testing.