NEW YORK (GenomeWeb) – Premaitha Health said today that the Brazilian Health Regulatory Agency (ANVISA) has approved its Iona noninvasive prenatal test as an in vitro diagnostic.
Last September, the agency had already granted the Iona test Brazilian Good Manufacturing Practice (B-GMP) approval, a requirement to register it with ANVISA.
Premaitha said it is now seeking commercial partners in Brazil to make the test available in the country.
"Commercializing the Iona test in this significant South American market is another key step in Premaitha's diversification and de-risking strategy," said Premaitha CEO Stephen Little in a statement. "Whilst the territory will not be immediately revenue generating, with over 3 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."