ISO certification has been approved for the manufacturing systems, while it also passed an audit under the EU's In Vitro Diagnostic Medical Device Directive, a requirement for IONA to be sold in Europe.
Stephen Little, Premaitha's chief executive, said: “We are making clear progress in achieving the CE-mark for the IONA test and its commercial launch.
"The ISO certification and Annex IV approval provide evidence of the quality of our world-class operational and commercial functions, and we anticipate receipt of the CE-mark very shortly.
"We look forward to bringing this ground-breaking screening test to market, making it available to any pregnant woman who needs it.”
Broker Panmure Gordon added that while a bit technical, the news was good for investors: "These are effectively the final administrative steps prior to CE-mark for the IONA test, which management now expects in February.
"We had previously anticipated this in 'early 2015', and it looks like Premaitha is going to come in on time."
The broker raised its price target to 25p from 23p and kept its buy recommendation.
Shares rose to 21p.