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Quick test for MRSA infections OK'd
FDA cleared for marketing BD Diagnostics' GeneOhm™ StaphSR assay that uses molecular methods to determine whether a blood sample contains Staphylococcus aureus bacterium. It's the first rapid blood test for the drug-resistant MRSA (methicillin-resistant Staphylococcus aureus), which can cause deadly infections.
The agency cleared the new assay based on results of a clinical trial at five locations in which the test identified 100% of the MRSA-positive specimens and more than 98% of the more common staph specimens. To preserve the integrity of positive test results, FDA says, 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 to treatment.
FDA looking at new ESA risk data
FDA is reviewing results from two studies it says provide further evidence of risks of erythropoiesis-stimulating agents (ESAs). The agency says the studies show that patients with breast or advanced cervical cancers who received ESAs (Aranesp®, Epogen®, and Procrit®) to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn't receive the anemia drug.
The two latest studies were not among six studies that were described in revised ESA labeling approved in November 2007 that strengthened warnings about ESAs in cancer patients. FDA said it was reviewing the new data and would ask an advisory committee to reconsider ESA risks and benefits and whether additional regulatory action is needed.