Leading Urologists Present Studies at the American Urological Association Supporting Use of the NMP22(R) BladderChek(R) Test for
23 Mayo 2007 - 7:00AM
Business Wire
Matritech�s (Amex: MZT) NMP22� BladderChek� Test was recognized by
leading clinical investigators at the 2007 annual meeting of the
American Urological Association (AUA) for use in diagnosing and
managing bladder cancer. New information showing the reliability of
the test as a diagnostic tool in evaluating patients with risk
factors for bladder cancer was also presented. People at risk for
bladder cancer include long-time smokers, workers in manufacturing
areas where particulate matter is concentrated, workers who
encounter chemical vapors including hair dyes, and fire fighters
who are exposed to toxic fumes. During the past year, the NMP22
BladderChek Test has increasingly been used in screening programs
for firefighters, most recently by the city of San Francisco, and
by occupational health groups to test people in high-risk
occupations for bladder cancer. Highlights from the NMP22
BladderChek Test presentations included: The NMP22 BladderChek Test
will be used in an independent large scale multicenter bladder
cancer screening study led by M.D. Anderson Cancer Center. A
positive NMP22 BladderChek Test result during initial treatment was
associated with a significantly greater risk of tumor recurrence
within one year of follow up. The reliability of a positive test
result, the positive predictive value (PPV), of the NMP22
BladderChek Test increases in patients at higher risk for bladder
cancer. For example: in men, the PPV of the NMP22 BladderChek Test
was higher among those who were older, smokers and patients with
gross hematuria (factors considered to increase risk for bladder
cancer). the negative predictive value (NPV), or reliability of a
negative test result, is enhanced in lower risk patients, up to
100% in women under age 65. The NMP22 BladderChek Test was included
in the AUA State-of-the-Art Lecture: Is Screening for Bladder
Cancer Ready for Prime Time?� delivered by H. Barton Grossman,
M.D., Deputy Chairman, Department of Urology, M.D. Anderson Cancer
Center, Houston, TX; and the subject of two discussed poster
presentations, �Impact of Risk Factors on the Performance of a
Point-of-Care Bladder Cancer Test,� by Yair Lotan, M.D., University
of Texas, Southwestern Medical Center, and �NMP22 as an Adjunct to
Urine Cytology and Cystoscopy in Follow-up of Superficial TCC of
the Urinary Bladder,� by Narmada P. Gupta, M.D., All India
Institute of Medical Sciences, New Delhi, India. In his lecture,
Dr. Grossman drew attention to a several clinical screening studies
of groups at risk for bladder cancer. He remarked that the Lotan,
et al study (Cancer 9/1/2006), �is a bench mark for identifying
suitable populations for screening as well as the cost benefit of
screening for bladder cancer.� He announced a large scale
multi-site screening study that he is heading from the M.D.
Anderson Cancer Center, which will get underway in the next several
months. The other sites participating in the study to screen adult
male smokers for bladder cancer include: Baylor University,
University of Rochester, University of Wisconsin, University of
Florida, and Universit� Laval in Montreal. Dr. Lotan presented new
information from the NMP22 Investigation Group showing the use of
the NMP22 BladderChek Test as a diagnostic tool in evaluating
patients with risk factors for bladder cancer. In his poster
presentation, he highlighted data that showed positive predictive
value increased in patients at higher risk for bladder cancer. The
predictive value of the NMP22 BladderChek Test demonstrates its
utility as a diagnostic tool to help physicians with patient
diagnosis and a management plan. Dr. Lotan has previously published
results from his analyses which showed that screening for bladder
cancer can save money as well as lives, by finding more cancers
before they become muscle invasive. If testing is focused on groups
at high risk and conducted with the NMP22� BladderChek� Test the
money saved in treatment expense is greater than the cost of
screening. An interview with Dr. Marshall Stoller, professor and
Vice Chairman, Department of Urology, University of California, San
Francisco (UCSF) School of Medicine and urologist at the UCSF
Medical Center and Dr. Kirsten Greene also of UCSF, focused on
their research on the increased risk firefighters have of getting
bladder cancer. They are working with the San Francisco Fire
Department that is using the NMP22 BladderChek Test in an annual
bladder cancer screening program for retired and active
firefighters. Dr. Greene commented �Currently we have screened
1,000 active and 500 retired firefighters. We are going to be able
to look at all aspects of firefighter health, including their risk
for bladder cancer. We are not just concerned about San Francisco
firefighters; we are concerned about all firefighters across this
country. The goal of the study is to see if a firefighter is at
increased risk for bladder cancer because of their job. If fighting
fires is a unique risk, as urologists we need to ask our patients
about (their exposure) so we can treat them optimally.� Dr.
Marshall Stoller added, �95 percent of the candidates have been
screened for bladder cancer. [A]nd this data will be used as
baseline to assess if their continual exposure to a variety of
fires may increase their risk of malignancies. We also hope to
understand if the firefighters who fought primarily wood-based
fires 10, 15, 20 years ago versus today�s fires that include a lot
of plastics have different risks for developing bladder cancer.�
Dr. Grossman also commented on the San Francisco firefighters
screening program and the UCSF study during his lecture saying, �I
enthusiastically support the UCSF firefighter screening study and
look forward to the results.� During other AUA moderated poster
sessions on bladder cancer, Dr. Gupta reported on an international
study of patients with bladder cancer. Findings showed that
patients with a positive NMP22 BladderChek Test result at their
initial diagnosis were at greater risk for bladder cancer
recurrence within one year of follow up compared to those who had a
negative NMP22 BladderChek Test result upon the initial diagnosis
of their cancer. About the NMP22� BladderChek� Test The NMP22�
BladderChek� Test was developed and commercialized by Matritech, a
leading developer and marketer of protein-based diagnostic products
for the early detection of cancer. The NMP22 BladderChek Test
detects elevated levels of the NMP22 protein marker in a single
urine sample. Most healthy individuals have very small amounts of
the NMP22 protein marker in their urine, but bladder cancer
patients commonly have elevated NMP22 marker levels, even at early
stages of the disease. The NMP22 BladderChek Test, a painless and
noninvasive assay, is the only in-office test approved by the FDA
for both the diagnosis and monitoring of bladder cancer. It is used
in a physician�s office, requires only four drops of urine and
results are available in 30 minutes � during the patient visit,
allowing a rapid and accurate way to aid in the detection of
bladder cancer. The NMP22 BladderChek Test is reimbursed by
Medicare and many medical insurers and has an average cost of less
than $30. It also has been shown to detect over three times as many
cancers as the commonly used laboratory based urine cytology test.
Two studies published in the Journal of the American Medical
Association (JAMA) in February 2005 and January 2006 reported on
clinical data showing the NMP22 BladderChek Test used in
combination with cystoscopy for the diagnosis and monitoring of
bladder cancer detected up to 99% of bladder malignancies. The
NMP22� BladderChek� Test also detected cancers that were missed
during an initial cystoscopic examination, most of which were high
grade. In other clinical study analyses it was shown to detect 100%
of the aggressive tumors, one of which was muscle invasive, in
women with symptoms or risk factors for bladder cancer. It was also
reported to detect all the transitional cell cancers that occurred
in the upper urinary tract of patients with risk factors or
symptoms of bladder cancer. Cystoscopy did not identify these
tumors because they were outside the viewing area of the
instrument. The San Francisco Fire Department is using the NMP22
BladderChek Test in an annual screening program of active and
retired firefighters for bladder cancer. In addition to San
Francisco, voluntary screening of firefighters with the NMP22
BladderChek Test is on-going or has occurred in a number of smaller
communities throughout the country. Legislation providing for the
screening of firefighters is being considered in Rhode Island,
Florida, New York, Vermont and Massachusetts. The NMP22 BladderChek
Test is also being used by local wellness and/or occupational
health programs to test individuals in Arizona, Colorado,
Wisconsin, Texas, Michigan, Kentucky, New York, Massachusetts,
Washington, DC and Rhode Island. About Matritech Matritech is using
its patented proteomics technology to develop diagnostics for the
detection of a variety of cancers. The Company's first two
products, the NMP22� Test Kit and NMP22� BladderChek� Test, have
been FDA approved for the monitoring and diagnosis of bladder
cancer. The NMP22 BladderChek Test is based on Matritech's
proprietary nuclear matrix protein (NMP) technology, which
correlates levels of NMPs in body fluids to the presence of cancer.
Beginning with a patent portfolio licensed exclusively from the
Massachusetts Institute of Technology (MIT), Matritech�s patent
portfolio has grown to 14 other U.S. patents. In addition to the
NMP22 protein marker utilized in the NMP22 Test Kit and NMP22
BladderChek Test, the Company has discovered other proteins
associated with cervical, breast, prostate, and colon cancer. The
Company�s goal is to utilize protein markers to develop, through
its own research staff and through strategic alliances, clinical
applications to detect cancer. More information about Matritech is
available at www.matritech.com. Statement under the Private
Securities Litigation Reform Act Any forward-looking statements
relate to the Company's current expectations of the Company�s NMP22
products and technology. Actual results may differ materially from
those predicted in such forward-looking statements due to the risks
and uncertainties inherent in the Company�s business, including
without limitation risks and uncertainties including those detailed
in the Company's periodic reports and registration statements as
filed with the Securities and Exchange Commission. These
forward-looking statements are neither promises nor guarantees.
There can be no assurance that the Company's expectations for its
products will be achieved. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. Matritech undertakes no responsibility to
revise or update any such forward-looking information.
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