Cepheid’s Diagnostic Test Categorized ‘Moderate Complexity’ by FDA

The FDA categorized Cepheid’s Xpert blood culture test for methicillin-resistant Staphylococcus aureus and Staphylococcus aureus as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments. The test, which was cleared by the FDA last month, is the first molecular diagnostic test for positive blood culture bottles to receive the categorization, according to Cepheid.