Premaitha Health has announced that the IONA test has been approved by Brazil’s regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), for sale as an in vitro diagnostic test.
In September 2017, Premaitha announced that the its IONAhad been approved by ANVISA for Brazilian Good Manufacturing Practice (B-GMP), which was required for Premaitha to move on with this application to register the IONA test with ANVISA.
Premaitha says it is now seeking commercial partners in Brazil to bring the benefits of non-invasive prenatal testing to pregnant women and their clinicians in the country.
Premaitha’s IONA test estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions. The test is performed on a maternal blood sample, containing traces of fetal DNA, which is then analysed using next generation DNA sequencing technology.
Dr Stephen Little, CEO of Premaitha, said: “Commercialising the IONA test in this significant South American market is another key step in Premaitha’s diversification and de-risking strategy. Whilst the territory will not be immediately revenue generating, with over three million births per annum, we anticipate Brazil will become a major market for Premaitha and that it will in due course provide a springboard to other South and Central America regions.
“Furthermore, the rapid regulatory approval process is another endorsement of the quality management system Premaitha has built from the outset that is of a calibre suitable for multiple regulatory regimes of the highest standards globally.”