Premaitha's IONA test given green light by Brazilian regulator

International molecular diagnostics group Premaitha Health announced on Monday that its IONA test product has been approved by Brazil's regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), for sale as an in vitro diagnostic test.

The AIM-traded firm had announced in September last year that the IONA test had been approved by ANVISA for Brazilian ‘Good Manufacturing Practice’ (B-GMP), which was required to enable Premaitha to proceed with its official application to register the product with ANVISA, which was completed ahead of expectations in under three months.

It said it was now seeking commercial partners in Brazil to bring non-invasive prenatal testing product to pregnant women and their clinicians in the country.

Premaitha said its IONA test estimated 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 what the company described as “next generation” DNA sequencing technology. It said the test is “highly accurate”, and significantly reduced the number of women who were unnecessarily subjected to risky, invasive follow up procedures to diagnose Down's syndrome and other genetic conditions.

“Commercialising the IONA test in this significant South American market is another key step in Premaitha's diversification and de-risking strategy,” said CEO Dr Stephen Little.

“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.”