FDA approves marketing of quicker MRSA test

The FDA Dec. 5 approved the marketing of a new diagnostic test for MRSA from Roche Molecular Systems that yields results hours faster than traditional tests. 

MRSA is a common cause of hospital-acquired infections and can lead to serious illness and death. CDC data shows that about 5 percent of hospital patients carry MRSA, though not all carriers develop an infection. 

MRSA is resistant to many common antibiotics, so infections can be very hard to treat and control. The CDC estimates that there were more than 10,000 MRSA-related deaths in 2017.

The new test, called the cobas vivoDx MRSA test, tests for MRSA in as little as five hours, compared to 24-48 hours for traditional MRSA tests. It uses bacteriophage technology based on bioluminescence to detect MRSA from nasal swabs. 

In performance studies, cobas vivoDx correctly identified MRSA in about 90 percent of samples where MRSA was present, and correctly identified no MRSA in 98.6 percent of samples that did not have MRSA present.

Read the full news release here

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