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FDA Clears Faster Blood Test for the Market

Listeria, MRSA, Streptococcus, and Enterococcus can all be identified much quicker by  the Verigene GP Blood  Culture Nuclear Acid Test (BC-GP), which got marketing approval from the U.S, Food and Drug Administration (FDA).

The Verigene test is manufactured by Northbrook, IL-based Nanosphere.

FDA’s decision was based on the 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 quicker Verigene test was consistent with traditional blood culture methods 93 percent of the time.

FDA said BC-GP testing would make it possible to identify potentially serious illness-causing bacteria just hours after a positive blood culture.  It is the first nuclear acid test that can identify 12 different bacteria types known to cause bloodstream infections.

Traditional tests require two to four days to produce bacterial identification and resistance results. The new tests takes just a few hours.

Alberto Gutierrez, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety at the Center for Devices and Radiological health, said the new test will allow doctors to treat patients quickly with the correct antibiotics.

Photo: Verigene’s test device

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