FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria | FDA

FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria | FDA

FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed. “Diagnostics that are able to provide accurate results more quickly can offer health care providers an advantage when trying to prevent and contain the spread of resistant bacteria,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s authorization adds a new tool in the fight to...

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