FDA OKs 1st Quick MRSA Blood Test
BD GeneOhm Test Delivers Results in 2 Hours, Says FDA
Jan. 2, 2008 -- The FDA today announced that it has cleared for marketing the first rapid blood test for MRSA (methicillin-resistant Staphylococcus aureus), a drug-resistant staph bacterium that can cause deadly infections.
The new MRSA blood test -- called the BD GeneOhm StaphSR assay -- delivers results in two hours. Other tests take several days.
"The BD GeneOhm test is good news for the public health community," the FDA's Daniel Schultz, MD, says in a news release. The new test allows for "more effective diagnosis and treatment," says Schultz, who directs the FDA's Center for Devices and Radiological Health.
New MRSA Test
The new MRSA test uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or from more common, less dangerous staph bacteria that can still be treated with the antibiotic methicillin.
The FDA cleared the BD GeneOhm test based on the results of a clinical trial in which the test identified 100% of MRSA-positive specimens and more than 98% of more common, less dangerous staph specimens.
The FDA cautions that the new test should be used only in patients suspected of a staph infection, not to monitor treatment of staph infections.
The test, which shouldn't be used as the sole basis for MRSA diagnosis, doesn't rule out other complicating conditions or infections, the FDA also notes.
The BD GeneOhm StaphSR test is made by BD Diagnostics of Franklin Lakes, N.J.