Healthcare Industry News: bladder cancer
News Release - May 23, 2007
Leading Urologists Present Studies at the American Urological Association Supporting Use of the NMP22(R) BladderChek(R) Test for Diagnosing and Managing Bladder CancerNEWTON, Mass.--(HSMN NewsFeed)--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.
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 Universite 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.
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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