FDA clears Parvoviris B19 tests by Biotrin

The US Food and Drug Administration (FDA) have cleared for sale in the US the propriety Parvovirus B19 tests made by Irish-based…

The US Food and Drug Administration (FDA) have cleared for sale in the US the propriety Parvovirus B19 tests made by Irish-based company Biotrin International.

The FDA approved the Biotrin tests for pregnant women suspected of exposure to Parvovirus B19 and for Fifth Disease, a common childhood illness.

The Parvovirus B19 infection is a common but mild illness, similar to rubella infection. However, in pregnant women it can cause miscarriages and foetal infection.

"The achievement represents a milestone for Biotrin, as it is our first FDA approval and it is a testament to the great efforts of our dedicated staff and our team of clinical regulatory advisors," said Dr Cormac Kilty, President of Biotrin International.

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Biotrin has its manufacturing, research and development, and marketing facilities in Dublin.