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October 12 2007 - Valencia CA. - Physicians & TB controllers around thecountry can now quickly and accurately detect M. tuberculosis infection withtoday's U.S. Food and Drug Administration (FDA) approval of QuantiFERON(R)-TBGold In-Tube (QFT(TM)). This blood test detects cellular immune responses toproteins specifically associated with tuberculosis (TB) infection. It replacesthe original QuantiFERON(R)-TB Gold, and offers the same specificity andaccuracy advantages. In addition, the new In-Tube format, already widely usedin Europe and Asia, simplifies testing and fits with existing laboratoryequipment, giving convenient TB testing from Kalispell to Key West. Both testsreplace the 100-year-old tuberculin skin test (TST).
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CEO of Cellestis, Dr Tony Radford, comments, "With the In-Tube system, theblood incubation requires virtually no labor and no set-up time. It makes aQFT(TM) test as simple as a routine antibody test and extends the availabilityof QFT(TM) testing by streamlining logistics to allow the initial incubationprocess 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 asa better process fit with hospitals and labs."
The TST, which involves a crude tuberculosis extract injected into theskin, is over 100 years old. Despite its limitations, it is widely used fordetecting TB infection. Significantly, the TST is often confounded in personsvaccinated with Bacillus Calmette-Guerin (BCG) (TB vaccination), as well asthose exposed to some environmental bacteria, giving many people a false-positive TST results. The TST has poor reproducibility and requires twopatient encounters; one to inject the subject and a second, 2-3 days later, toread the inflammation it may produce. Measuring the inflammation requirestrained medical personnel but is still highly subjective, and is notorious forinaccuracy. This leads to poor use of valuable medical resources, and the needfor a second clinic visit means many people fail to have their TST read.
QFT(TM) is supported by data from over 100 clinical publications, requiresa single blood test, and gives objective and reproducible results. The In-tubeformat simplifies testing logistics, enabling remote location bloodcollection. It measures immune responses to peptides that simulate M.tuberculosis proteins, which are not present in the BCG vaccine or most non-tuberculosis mycobacteria. Thus, QFT(TM) is 99% specific and a positive testresult is strongly predictive of true infection with M. tuberculosis. Aspeople suspected of TB infection are normally recommended for TB therapy,which carries risks of liver toxicity and nerve damage, use of the highlyspecific QFT(TM) test will reduce unnecessary therapy and overtreatment,therefore having significant medical benefit.
QFT(TM) provides a new standard for TB control and gives the US TB controlcommunity an effective, reliable and accurate screening method. In addition,QFT(TM) yields dramatic cost savings in medical staff time and by eliminatingthe common false-positive results of the TST. For TB control programs acrossthe nation, QFT(TM) can relieve the medical, logistic, administrative and costburden associated with TB testing compliance.
About Cellestis:
Cellestis is a listed Australian biotechnology company commercialisingQuantiFERON(R) technology for diagnosing TB and other diseases worldwide.QuantiFERON(R)-TB Gold tests for the presence or absence of a protein (gamma-interferon) produced by a patient's white blood cells after stimulation withspecific TB proteins. The test has received regulatory and policy approvals inthe USA, Japan, Europe and elsewhere. The Company operates throughsubs
