Consumer Update

First Quick Test for Deadly, Drug-Resistant MRSA Bacterium

FDA has cleared for marketing the first rapid blood test for a deadly and drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus).

Methicillin is an antibiotic that has been used successfully to treat infections from the Staphylococcus aureus bacterium. Over the years, the staph bacterium mutated and spawned MRSA, a strain that is resistant to methicillin and has a higher rate of being fatal. The MRSA bacterium can cause potentially life-threatening conditions such as blood stream infections, surgical site infections, and pneumonia.

The blood test, called the BD GeneOhm StaphSR Assay, can 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.

“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 Daniel Schultz, M.D., Director of FDA’s Center for Devices and Radiological Health.

The BD GeneOhm StaphSR test is manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J.

Who is at Risk for Staph Infections?
Staph infections occur most frequently among people in hospitals and health care facilities (such as nursing homes and dialysis centers) who have weakened immune systems. But they can also occur in healthy people.

For More Information
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01768.html

Date Posted: January 10, 2008