MicroPhage Gets CE Marking for Rapid Staph Test

MicroPhage received marketing authorization in Europe for its instrument-free, rapid test that can identify Staphylococcus aureus and determine methicillin resistance or susceptibility in five hours. The company plans to file a 510(k) application for the product soon with the FDA, it says in a statement Monday. It is comparing the test to “gold standard” lab tests, which can take up to three days to deliver results, in a clinical study at four medical centers in the U.S.