FDA Clears First Quick Test For Drug-Resistant Staph Infections

The FDA announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections. The BD GeneOhm StaphSR Assay uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin. In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient’s response to treatment. Test results should not be used as the sole basis for diagnosis as they may reflect the bacteria’s presence in patients who have been successfully treated for staph infections. Also, the test will not rule out other complicating conditions or infections.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01768.html