Abbott Laboratories and artus have gained European approval for their RealArt HPA Coronavirus LC RT Reagents, a diagnostic test for Severe Acute Respiratory Syndrome (SARS).
Developed by artus in collaboration with the Bernhard-Nocht-Institute for Tropical Medicine in Hamburg, Germany, the RealArt HPA Coronavirus test is the first SARS test get the CE mark.
"This is a significant step in our efforts to provide a reliable, widely available test for SARS," said James Koziarz, vice president, diagnostic products research and development, Abbott Laboratories. In addition to the European Union, artus and Abbott are working with regulatory agencies in other countries, including the US and Canada, to determine the requirements necessary in each country to introduce the RealArt HPA Coronavirus test.
artus first introduced the test - based on a technology known as polymerase chain reaction - in April to countries in Asia and Europe and provided it to laboratories under the direction of the World Health Organisation (WHO).
In May, Abbott and artus announced a worldwide marketing and distribution agreement for the RealArt HPA Coronavirus test. Under the agreement, artus will manufacture the test and Abbott, through its alliance with Celera Diagnostics, will market and distribute it in the US, Canada, Germany, the UK and Austria.