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Cellestis Receives FDA Approval for Blood Test for Detecting Tuberculosis
Date:10/12/2007

MELBOURNE, Australia, Oct. 12 /PRNewswire/ -- QuantiFERON(R)-TB Gold In- Tube is Poised to Set the Standard from Kalispell to Key West for Accurate & Effective Tuberculosis Screening

October 12 2007 - Valencia CA. - Physicians & TB controllers around the country can now quickly and accurately detect M. tuberculosis infection with today's U.S. Food and Drug Administration (FDA) approval of QuantiFERON(R)-TB Gold In-Tube (QFT(TM)). This blood test detects cellular immune responses to proteins specifically associated with tuberculosis (TB) infection. It replaces the original QuantiFERON(R)-TB Gold, and offers the same specificity and accuracy advantages. In addition, the new In-Tube format, already widely used in Europe and Asia, simplifies testing and fits with existing laboratory equipment, giving convenient TB testing from Kalispell to Key West. Both tests replace the 100-year-old tuberculin skin test (TST).

CEO of Cellestis, Dr Tony Radford, comments, "With the In-Tube system, the blood incubation requires virtually no labor and no set-up time. It makes a QFT(TM) test as simple as a routine antibody test and extends the availability of QFT(TM) testing by streamlining logistics to allow the initial incubation process to be done almost anywhere. The FDA approval now permits our U.S. customers to enjoy the cost-savings, and quality result of In-Tube, as well as a better process fit with hospitals and labs."

The TST, which involves a crude tuberculosis extract injected into the skin, is over 100 years old. Despite its limitations, it is widely used for detecting TB infection. Significantly, the TST is often confounded in persons vaccinated with Bacillus Calmette-Guerin (BCG) (TB vaccination), as well as those exposed to some environmental bacteria, giving many people a false- positive TST results. The TST has poor reproducibility and requires two patient encounters; one to inject the subject and a second, 2-3 days later, to read the inflammatio
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SOURCE Cellestis Inc.
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