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FDA Approves Bloodstream Bacteria Test

A new test for 12 different types of bacteria that cause bloodstream infections has been approved by the FDA.

The test is much faster than current laboratory techniques, and can pickup on signs of bacterial growth within hours of the infection starting. Current tests require waiting as long as four days, which obviously exposes the patient to a longer wait time and risk, whilst giving the disease more time to establish itself.

The test, known as the Verigene GP Blood Culture Nucleic Acid Test (BC-GP) is able to identify different types of Staphylococcus, (including methicillin-resistant Staphylococcus aureus or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant Enterococci or VRE), and Listeria.

Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health said:
 
 

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