FDA: New Test Detects TB and Antibiotic Resistance
New assay both tests for TB and detects drug-resistant strains in about two hours
FRIDAY, July 26 (HealthDay News) -- A new test to detect bacteria that cause tuberculosis (TB) and simultaneously determine if the bacteria are resistant to the antibiotic rifampin has been approved by the U.S. Food and Drug Administration.
The Xpert MTB/RIF Assay is less complex to administer than other screening tests for TB. Results are available in about two hours, while traditional methods to detect TB could take up to several months, the agency said in a news release.
People with weakened immune systems are most likely to develop full-blown TB once infected with the disease-causing bacteria, the FDA said. TB is a leading killer globally of people with HIV/AIDS.
"Less complex tests such as the Xpert MTB/RIF Assay can be used in more diverse settings," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement. "The early and rapid detection of rifampin-resistant TB can help curb the spread of drug-resistant TB, a major public health threat."
The test is manufactured and marketed by Cepheid, based in Sunnyvale, Calif.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm362602.htm )