Test is First for Detecting, Identifying 12 Respiratory Viruses


FDA News Digest
January 7, 2008


Test is First for Detecting, Identifying 12 Respiratory Viruses

FDA has cleared for marketing the xTAG Respiratory Viral Panel, a test that simultaneously detects and identifies 12 specific respiratory viruses. It is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of flu for humans and has been the cause of major epidemics.



FDA Clears Rapid Test for Drug-Resistant Staph Infections

FDA has cleared for marketing the BD GeneOhm StaphSR Assay, the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections. Methicillin is an antibiotic used successfully to treat infections from the Staphylococcus aureus bacterium. But over the years, the staph bacterium has mutated and spawned MRSA, a strain resistant to methicillin with a higher rate of being fatal. The new test uses molecular methods to identify whether a blood sample has genetic material from the MRSA bacterium or a more common, less dangerous staph bacterium that can still be treated with methicillin.



Voluven Approved to Treat Blood Volume Loss After Surgery

FDA has approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery. Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so remaining red blood cells can continue to deliver needed oxygen to the body's tissues.


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