Cellestis Receives FDA Approval for QuantiFERON(R)-TB GOLD for Detection of Immune Responses to Tuberculosis
VALENCIA, Calif., Dec. 3 /PRNewswire/ -- Cellestis Inc. announced today U.S. Food and Drug Administration (FDA) approval of QuantiFERON(R)-TB GOLD, an indirect test for M. tuberculosis infection. This breakthrough blood test detects immune responses to specific proteins, associated with tuberculosis (TB) infection. QuantiFERON(R)-TB GOLD is a modern alternative to the 114-year-old tuberculin skin test (TST), offering unmatched specificity and finally providing clinicians with an accurate, reliable and convenient TB diagnostic tool. QuantiFERON(R)-TB GOLD is well-poised to set a new standard of care for TB control, and provide the healthcare community with an effective and economical screening method. "One of the greatest problems in combating this disease has been the lack of a solid detection strategy. We believe that QuantiFERON(R)-TB GOLD will meet this previously unmet medical need and become the gold standard for tuberculosis screening," said Tony Radford, Ph.D., CEO of Cellestis Inc. "There are numerous markets where our test will have a significant impact, including in prisons and jails, public health TB programs, and for screening recent immigrants, healthcare workers and military personnel. We are currently working with healthcare providers across the U.S. to introduce QuantiFERON(R)-TB GOLD as an alternative to the TST."
Extensive clinical data has demonstrated far superior specificity (>99 percent) of QuantiFERON(R)-TB GOLD over the TST. In addition, QuantiFERON(R)-TB GOLD is set to yield dramatic cost savings in terms of medical staff time and the elimination of common false-positive results. For hospitals and health departments, such a test would relieve the huge administrative and cost burden associated with maintaining TB testing compliance. According to a recent study (Lambert et al. Infection Control and Hospital Epidemiology Nov. 2003), researchers observed that the cost of running a TB control program using the TST is considerably more expensive than the simple cost of the TST supplies, given the labor required to successfully perform the TST. Specifically, costs to a hospital ranged from $41 to $362 per employee, with the TST supplies representing less than 1.5 percent of the total cost of the program. QuantiFERON(R)-TB GOLD is an in vitro diagnostic test unaffected by subjective interpretation of the physician or nurse, previous BCG vaccination, and cross-reactivity with most non-tuberculous or environmental mycobacteria. These capabilities mean virtual elimination of those TST false-positive individuals normally recommended for unnecessary and potentially harmful TB therapy. For the U.S. born population, the false-positive rate due to non-tuberculous mycobacterial infections can be as much as 50 percent of all TST responses (von Reyn et al. Int J. Tuberc Lung Dis 5(12), 2001). While for foreign born individuals living in the U.S., cross-reactivity to past TB vaccination with Bacillus Calmette-Guerin (BCG) is a common cause of false-positive TST responses.
The Traditional Skin Test
The TST originated in the 1890's -- the decade that saw the invention of the gas-powered automobile -- and until now was the only widely used method for detecting latent TB infection. However, the TST has many limitations and its effectiveness for controlling TB in the U.S. was questioned in the U.S. Institute of Medicine's 2000 major report, Ending Neglect, which stated that "the greatest needs in the United States are new diagnostic tools for the more accurate identification of individuals who are truly infected." Interpreting the TST is highly subjective, the test has poor reproducibility and requires two patient encounters; one to inject the subject and a second to read the inflammation it may produce. Commonly, up to 30 percent of individuals tested do not return to have their results read. Of major significance, the TST is confounded by previous vaccination with BCG, as well as exposure to non-tuberculosis mycobacteria, resulting in a high rate of people with TST false-positive results. In contrast, QuantiFERON(R)-TB GOLD technology measures immune responses to peptides that simulate M. tuberculosis proteins which are not present in the BCG vaccine or most non-tuberculosis mycobacteria. Thus, QuantiFERON(R)-TB GOLD is highly specific and a positive test result is strongly predictive of true infection with M. tuberculosis.
The Global TB Epidemic
Declared a global epidemic by the World Health Organization (WHO) in 1993, TB is the largest microbial killer in the world, responsible for more than two million deaths each year. It is an airborne disease that is adapting to misused medications, growing stronger and becoming more multi-drug-resistant.
While the overall TB incidence in the U.S. is slowly decreasing, TB is resurfacing in several, "hot spot" metropolitan areas due to large immigrant and migrant populations, as well as individuals with immunosuppressive diseases such as HIV. The CDC estimates that 10 to 15 million U.S. residents are infected with TB in its latent (non-symptomatic) phase. Infected individuals are at risk of developing active TB disease, and becoming the source of continual transmission.
About Cellestis and QuantiFERON(R) Technology
QuantiFERON(R) technology was developed by Australian researchers for the detection of TB infection in cattle.
CSL Limited acquired an exclusive license to the patented technology and undertook the development of a diagnostic test for human TB in the early 1990s. Cellestis Limited was chosen to commercialize the diagnostic test now known as QuantiFERON(R)-TB. Cellestis has improved on QuantiFERON(R)-TB to make QuantiFERON(R)-TB GOLD, which eliminates known causes of false-positive response by using synthetic versions of TB proteins (peptides) selected for their specificity and capacity to detect TB immune responses.
QuantiFERON(R) technology is an effective and quick blood test for gamma interferon, a protein that indicates an immune response. The technology was first approved for TB by the U.S. Food and Drug Administration (FDA) in 2001 and was named as one of the most significant new indications to impact patient care in the 2002 FDA annual report. Only 11 out of the thousands of devices and diagnostics approved or cleared by the FDA were included on this list.
For further information, please contact Jill Hoffman, ext. 113, [email protected], or Marcy Pozzi, ext. 151, [email protected], both of FischerHealth, +1-310-577-7870.
CONTACT: Jill Hoffman, ext. 113, [email protected], or MarcyPozzi, ext. 151, [email protected], both of FischerHealth,+1-310-577-7870
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