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FDA NEWS RELEASE


For Immediate Release:
June 27, 2012
Media Inquiries: Michelle Bolek, 301-796-2973, michelle.bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
 
FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections
Test makes it possible to identify potentially serious illness causing bacteria hours after a positive blood culture
 
The U.S. Food and Drug Administration today allowed marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth. Traditional methods may require two to four days to produce bacterial identification and resistance results.
 
The Verigene GP Blood Culture Nucleic Acid Test (BC-GP) can identify different types of Staphylococcus, (including methicillin-resistant Staphylococcus aureus or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant Enterococci or VRE), and Listeria.
 
“Bloodstream infections are always treated with antimicrobial drugs, and it is essential to identify which antimicrobial drug is appropriate for a specific patient as quickly as possible,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA’s Center for Devices and Radiological Health. “This new test is an important tool that will help physicians treat patients quickly with the correct antibiotics.”
 
Bloodstream infections are one of the most common and serious illnesses found in U.S. hospitals. Bacteria entering the bloodstream can cause severe illness, including infections of the heart, kidney, and other vital organs. Without treatment, infection of vital organs can result in serious consequences, including death. 
 
The FDA based its decision on a study of 1,642 patient blood samples obtained from incubated blood culture bottles that contained gram positive bacteria. The study included a comparison of BC-GP and traditional blood culture laboratory methods. The BC-GP results were consistent with traditional blood culture methods in 93 percent to 100 percent of the comparisons.
 
The Verigene is manufactured by Nanosphere Inc. of Northbrook, Ill.
 
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 
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