FDA OKs First Fast Test for MRSA

The U.S. Food and Drug Administration announced Jan. 2 that it has cleared for marketing the first rapid blood test for MRSA (methicillin-resistant Staphylococcus aureus), which can cause deadly infections and has become a significant health concern within the past year. The strain of staph bacterium that is resistant to methicillin has a higher rate of being fatal.

The BD GeneOhm StaphSR Assay from BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J., uses molecular methods to determine whether a blood sample contains genetic material from the MRSA bacterium or the less dangerous staph bacterium that can be treated with methicillin. "The BD GeneOhm test is good news for the public health community. Rather than waiting more than two days for test results, health care personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment," said Dr. Daniel G. Schultz, director of FDA's Center for Devices and Radiological Health.

FDA said it cleared the test based on a clinical trial at five locations where it identified 100 percent of MRSA-positive specimens and more than 98 percent of the less dangerous staph specimens. The test should be used only in patients suspected of a staph infection, the agency said, and should not be used to monitor treatment for staph infections because it cannot quantify a patient's response to treatment.

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