Cepheid's drug-resistant TB test gets FDA nod (Reuters) - The U.S. Food and Drug Administration granted marketing approval to Cepheid's tuberculosis test that checks if the disease-causing bacteria carry antibiotic-resistant genetic markers. The test, Xpert MTB/RIF Assay, can simultaneously detect the bacteria that cause TB and whether the strain is resistant to rifampin, an important antibiotic used to treat the infection. The FDA said the ...
July 25, 2013 - Reuters via Yahoo! News
FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to ... The U.S. Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.
July 25, 2013 - U. S. Food and Drug Administration
Julie Gerberding in AllAfrica.com TB that is resistant to at least isoniazid and rifampin is called multidrug-resistant [MDR] TB,said Dr. Julie Gerberding, director of the US Centers for Disease Control and Prevention (CDC), in testimony before the subcommittee. "MDR-TB...