NEW YORK (GenomeWeb) – Premaitha today announced it has received the CE mark for its Iona test, the first in vitro diagnostic product for non-invasive prenatal testing to receive the certification, according to the UK-based company.
The Iona test uses next-generation sequencing technology to estimate the risk of a fetus having Down's syndrome, Edwards' syndrome, and Patau's syndrome by analyzing cell-free fetal DNA from a sample of maternal blood. The test covers the entire process, from DNA extraction to data analysis, with a standardized workflow and is both more sensitive and specific than the current standard of care, the firm said in a statement.
"The launch of a regulated NIPT test is fantastic news for pregnant women and the clinical team caring for them," Brenda Kelly, an obstetrician at Oxford University Hospitals, said in a statement. Currently, pregnant women in Europe can only access NIPT via tests provided by service laboratories, which involves sending a blood sample to the US or China. The Iona test can provide results within three days, as opposed to several weeks, Premaitha said.
It added that it will first launch the test in Europe, followed by a later launch in other territories recognizing the CE mark.
The firm announced it would seek CE mark for Iona in July, 2014, and received ISO 13485:2003 certification on Jan. 30.