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Cepheid Receives FDA Market Authorization for Xpert MTB/RIF
Date:7/25/2013

ory methods.

"Xpert MTB/RIF is the most technologically advanced test for TB ever developed, yet it is simple enough to be performed across multiple shifts in laboratories across the country," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "About one-third of the human population is infected with TB, but most do not have active disease that requires treatment. Ruling out active disease in TB suspects is a relatively common task of domestic clinical laboratories. We think that the Xpert MTB/RIF test will help to eliminate guesswork and deliver maximum medical value in the management of TB here in the U.S., as already demonstrated abroad."

In the early 1900s TB was the leading cause of death in the United States. Tuberculosis disease and deaths have declined steadily from the early 1900s due largely to the introduction of effective antibiotics and improvements in living conditions. While some improvements in global control of TB have been achieved over the last decade, TB continues to be a leading cause of death from an infectious disease in many countries. In 1993, the World Health Organization (WHO) declared TB a "global health emergency." 2

While TB in the U.S. is at its lowest level since 1953, rapid and accurate diagnosis of TB continues to be a challenge, especially among immunocompromised patients and the elderly. The symptoms of TB in its early stages are similar to many different types of infections, thus having an accurate test to rule out the disease is critical for managing patients in the U.S. According to the CDC, in 2012 63% of reported TB cases in the U.S. occurred in foreign-born persons, with case rates that were 11.5 times higher than among U.S. born persons.3  Yet, any nationality can fall victim to this disease. Returning U.S. travelers may also carry the disease and it can be just as deadly, especially if it
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