The test can identify the MRSA bacterium in two hours, rather than lab personnel having to wait more than two days for test results, the FDA said.

The Food & Drug Administration 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 such as blood stream infections, surgical site infections, or pneumonia.

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

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 which has a higher rate of being fatal.

"The BD GeneOhm test is good news for the public health community," said Daniel G. Schultz, MD, director of FDA’s Center for Devices & Radiological Health, in a January 2 announcement of test approval. "Rather than waiting more than two days for test results, healthcare personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment."

Staph infections occur most frequently among persons in hospitals, nursing homes, and dialysis centers who have weakened immune systems. Both types of bacteria also can infect healthy people.

The FDA has issued several caveats on approved use of the test. In order to preserve the integrity of positive test results:

— The test should be used only in patients suspected of a staph infection.

— It should not be used to monitor treatment for staph infections because it cannot quantify a patient’s response.

— Test results should not be used as the sole basis for diagnosis since 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, the FDA cautioned.

January 14, 2008 - Table of Contents

NIR January 14, 2008 (full PDF issue)

Medicare Revises Conversion Factor to Reflect Physician Fee Hike

CMS Uses Crosswalks to Set Fees for New Lab Codes in 2008

Senate Bill Introduced to Overhaul CLIA Cytology PT

Medicare Releases Lab Fee Schedule for 2008: What the Payment Policies Mean for Your Lab

FDA Okays First Rapid Blood Test for Drug-Resistant Staph

CMS to Delay Anti-Markup Rules for Certain Diagnostic Tests