FDA Okays Rapid Blood Test for MRSA

By Todd Neale
ROCKVILLE, Md., Jan. 2 -- The FDA today approved the first rapid blood test for methicillin-resistant Staphylococcus aureus (MRSA).
The BD GeneOhm StaphSR Assay can determine within two hours whether genetic material in a blood sample belongs to MRSA or a more treatable staph bacterium, according to the FDA. Tests currently used can take more than two days.
In October, the CDC announced a revised estimate of 94,360 invasive MRSA infections in 2005, up from 31,440 in 2000. (See: Invasive MRSA More Pervasive Than Suspected)
This was preceded by public concerns about the apparent rise of community-acquired MRSA.
The new test was cleared on the basis of a clinical trial that showed that the assay identified 100% of the MRSA specimens and 98% of the less dangerous staph bacteria.