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BD Diagnostics of Becton Dickinson & Co received clearance on Wednesday from the U.S. Food and Drug Administration for its GeneOhm StaphSr test, which can distinguish between deadly, drug resistant staph infections and more benign versions of the bacteria.
The test is designed to help physicians determine treatment for patients within two hours which is remarkable as the previous tests provided results only after two days and required more of technologists’ time.
The new test allows for more aggressive treatment of methicillin-resistant staphylococcus aureus, or MRSA, a virulent form of staph that is resistant to most common antibiotics.
"The BD GeneOhm test is good news for the public health community. Rather than waiting more than two days for test results, health-care personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment," Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement.
The new test was cleared by the FDA after clinical trials showed that it identified 100 percent of MRSA-positive specimens and more than 98 percent of more common, less dangerous staph specimens.
Shares were up $2.30, or 2.8 percent, to $85.88 in early trading on the New York Stock Exchange after climbing to $86.46.
Becton Dickinson, based in Franklin Lakes, is also working on rapid tests for two other deadly infections that are increasingly common in hospitals, vancomycin-resistant enterococci and c. difficile. This made analysts conclude that the unit could bring in hundreds of millions of dollars a year as more hospitals adopt the tests.
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