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 test is complicated but provides results in about two hours, compared with traditional methods that require one to three months. (r.reuters.com/sur89t)
The World Health Organization said in March that about a third of the global population is infected with the bacteria that causes TB and that about 4 percent of those newly infected are resistant to multiple drugs.
The WHO also said multi drug-resistant TB, a form of the infection that resists at least two drugs - isoniazid and rifampin - was responsible for 1.6 percent of TB cases in which drug susceptibility testing was done in 2011.
Cepheid shares closed at $34.53 on Thursday on the Nasdaq.
(Reporting by Pallavi Ail in Bangalore,)