Cellestis Receives FDA Approval for QuantiFERON®-TB GOLD for...

Cellestis Receives FDA Approval for QuantiFERON®-TB GOLD for Detection of
Immune Responses to Tuberculosis

- Test Poised to Replace the Tuberculin Skin Test and Raise the Standard of
Tuberculosis Screening Worldwide -

VALENCIA, Calif., Dec. 3 /PRNewswire/ -- Cellestis Inc. announced today
U.S. Food and Drug Administration (FDA) approval of QuantiFERON®-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®-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®-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®-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®-TB GOLD as an alternative to the TST."
Extensive clinical data has demonstrated far superior specificity
(>99 percent) of QuantiFERON®-TB GOLD over the TST. In addition,
QuantiFERON®-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®-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®-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®-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® Technology
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®-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.
QuantiFERON® 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.

SOURCE Cellestis Inc.
-0- 12/03/2004