FDA Authorizes Marketing of Novel Technology Diagnostic Test to Detect MRSA
On December 5, 2019, the FDA authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization. The new test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as little as 5 hours. Along with this authorization, the FDA is establishing special controls for this test type, including requirements relating to labeling and validation to address certain risks, such as false positives. Read the news release.