County of San Francisco First in Country to Diagnose Tuberculosis Infection With QuantiFERON(R)-TB GOLD Monday February 7, 8:06 am ET - Medi-Cal's Recent Approval of Reimbursement for Test Validates Clinical and Economic Advantages Over Outdated Tuberculin Skin Test (TST) -
VALENCIA, Calif., Feb. 7 /PRNewswire/ -- As part of its steadfast effort to control the spread of tuberculosis (TB), the San Francisco Health Department today became the first county health department in the U.S. to use QuantiFERON(R)-TB GOLD, an indirect test for TB infection. This follows closely on the heels of Medi-Cal reimbursement for the modern alternative to the 115-year-old tuberculin skin test (TST), which despite its widespread use is notoriously unreliable due to false-positive and false-negative results.
Approved by the FDA in December 2004, QuantiFERON-TB GOLD is a simple, one-step blood test that detects immune responses to specific proteins associated with infection by Mycobacteria Tuberculosis. By finally providing clinicians with an accurate, reliable and convenient TB diagnostic tool, the breakthrough test is well positioned to become the new gold standard for TB screening and control.
While the overall TB incidence in the U.S. is slowly decreasing, TB is resurfacing in several "hot spot" metropolitan areas, such as San Francisco, where 231 active TB cases were reported to the CDC in 2003 (13.6 per 100,000). As an international city with large immigrant and migrant populations, as well as a high number of individuals with immunosuppressive diseases such as HIV/AIDS, the San Francisco metropolitan area has one of the highest TB rates in the U.S. An untold number of individuals are infected with TB in its dormant, or latent, phase and are at risk of developing active TB disease and becoming highly contagious. Therefore, the accurate identification of people with latent TB infection is important in the prevention of further spread of the disease.
"Medi-Cal reimbursement of QuantiFERON-TB GOLD is a tremendous achievement because it opens the door for wider adoption in California, a state with several TB 'hot spots,'" said Tony Radford, Ph.D., CEO of Cellestis. "The urgent need for a new tool to more accurately identify individuals who are infected and those who are at risk of developing tuberculosis has been reinforced by a state that is a bellwether for the rest of the country."
QuantiFERON-TB GOLD is an in vitro diagnostic test unaffected by subjective interpretation, previous TB vaccination and cross-reactivity with most non-tuberculous or environmental mycobacteria. This means virtual elimination of TST false-positive individuals normally recommended for unnecessary and potentially harmful TB therapy. False-positive rates can be as high as 50 percent of all TST responses (von Reyn et al. Int J. Tuberc Lung Dis 5(12), 2001).
When compared with the TST, QuantiFERON-TB GOLD has been demonstrated to yield dramatic cost savings in terms of medical staff time and the elimination of common false-positive results. According to a recent study (Lambert et al. Infection Control and Hospital Epidemiology Nov. 2003), researchers found that the cost of running a TB control program using the TST is considerably more expensive than the simple cost of the 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.
"After FDA approval, the California TB Controllers Association began aggressively making the case to Medi-Cal for reimbursement of QuantiFERON-TB GOLD, realizing the importance of this new technology," said Dr. Masae Kawamura, TB controller for the City of San Francisco. "With large numbers of immigrants and high risk patients served by San Francisco's county health department, a more accurate test for TB has long been awaited. Now that Medi-Cal has approved payment of QuantiFERON-TB GOLD, San Francisco has a real chance of providing the public with a safer and more accurate test, without breaking the bank. QuantiFERON-TB GOLD will eliminate the waste of precious health resources from inaccurate skin tests and improve public safety by preventing unnecessary treatment."
National TB Controllers Association strongly advocates the use of FDA-approved blood test to diagnose latent TB infection
Further support for QuantiFERON-TB GOLD was provided by the National TB Controllers Association (NTCA) with the issue of their official position statement (January 2005), advocating the use of FDA approved in vitro diagnostic tests for diagnosis of latent TB infection. QuantiFERON-TB Gold is currently the only such test. The NTCA states that "...the TST has many limitations and that a new test to replace the TST has been sought for many years." The NTCA recognizes that various problems with the TST, including operational limitations, subjective interpretation, false positive and false negative results "...make the TST a frustrating test for patients and providers and have led to recommendations that are often poorly followed, accepted, or understood." The NTCA believes that "...blood assays done in vitro are likely to become the test of choice for most or all populations in the future."
About Cellestis and QuantiFERON Technology
Cellestis Ltd is a public company trading on the Australian Stock Exchange (ASX: CST - News) with a major subsidiary Cellestis Inc. in California. QuantiFERON 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-TB to make QuantiFERON-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.
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, for Cellestis
Source: Cellestis
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