The FDA has approved QuantiFERON®-TB GOLD, a new test for detection of immune responses to specific proteins associated with tuberculosis (TB) infection.

“One of the greatest problems in combating this disease has been the lack of a solid detection strategy,” says Tony Radford, PhD, CEO of Cellestis Inc. “We believe that QuantiFERON-TB GOLD will meet this previously unmet medical need and become the gold standard for tuberculosis screening. There are numerous markets where our test will have a significant impact, including in prisons and jails and public health TB programs, and for screening recent immigrants, health care workers, and military personnel. We are currently working with health care providers across the United States to introduce QuantiFERON-TB GOLD as an alternative to the TST [tuberculin skin test].”

According to Radford, extensive clinical data has demonstrated far superior specificity (greater than 99%) of QuantiFERON-TB GOLD over the TST. In addition, QuantiFERON-TB GOLD is an in vitro diagnostic test unaffected by subjective interpretation of the health care professional, previous BCG vaccination, and cross-reactivity with most nontuberculous or environmental mycobacteria. These capabilities mean virtual elimination of those TST false-positive individuals normally recommended for unnecessary and potentially harmful TB therapy. The QuantiFERON-TB GOLD is expected to yield dramatic cost savings in terms of medical staff time and the elimination of common false-positive results.

TB was declared a global epidemic by the World Health Organization in 1993. It is the largest microbial killer in the world, responsible for more than two million deaths each year. It is an airborne disease that is growing stronger and becoming more multidrug-resistant.

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