Healthcare Industry News: Bladder Cancer
News Release - March 24, 2006
NMP22(R) BladderChek(R) Test Detected 100% of Dangerous Tumors in Women at Risk for Bladder CancerWomen Have a Disproportionately Higher Death Rate from Bladder Cancer than Men
Clinical Results Presented at Society of Gynecologic Investigation Annual Meeting
NEWTON, Mass. & TORONTO--(HSMN NewsFeed)--March 24, 2006--Point-of-Care Test has utility as a Screening Tool for Women at Risk for Bladder Cancer
Two leading clinical investigators, a UCLA gynecologist and a noted urologist and author, presented clinical results for Matritech's (Amex: MZT ) NMP22® BladderChek® Test reporting it detected 100% of the aggressive tumors, one of which was muscle invasive, in women with symptoms or risk factors for Bladder Cancer. The NMP22 BladderChek Test was also positive for seven conditions that required biopsy for diagnosis. The data and the point-of-care NMP22 BladderChek Test were presented at the 53rd Annual Meeting of the Society for Gynecologic Investigation (SGI) in Toronto in a poster presentation, "Evaluation of a Point-Of-Care Assay for Detection of Bladder Cancer in Women at Risk."
The clinicians noted that the NMP22 BladderChek Test has the potential to be an effective screening tool in identifying aggressive lesions early and improving prognosis in women at risk for Bladder Cancer. In other clinical studies it was shown to be an effective adjunctive tool in the diagnosis and monitoring of Bladder Cancer - improving cancer detection to 99%.
The data and the NMP22 BladderChek Test were introduced at the SGI meeting by Michael G. Ross, M.D., M.P.H., Professor of Ob/Gyn and Public Health, UCLA School of Medicine and Public Health and Chairman, Department of Ob/Gyn, Harbor-UCLA Medical Center, Los Angeles and Giora Katz, M.D., LakeShore Urology, and Holy Family Medical Center, Manitowoc, WI. Dr. Katz, a urologist, is a co-author of two studies published within the last year in the Journal of the American Medical Association (JAMA) reporting clinical results in the detection of Bladder Cancer using the NMP22 BladderChek Test.
Commentary by the Authors
"This is good news for women and their doctors - we can detect Bladder Cancer earlier. Although Bladder Cancer hasn't been a major focus of gynecological medicine, it is a significant issue for women because the prevalence of Bladder Cancer is similar to ovarian and cervical cancers," said Dr. Ross. "Women tend to be diagnosed later than men. These data support our message to gynecological specialists: Bladder Cancer is very treatable if detected early."
Dr. Ross emphasized, "As gynecologists it's important to recognize our role in the early detection of Bladder Cancer. We now have the means to screen women for Bladder Cancer using a nuclear matrix protein assay, especially when hematuria (blood in the urine) is a presenting symptom. If the NMP22 test is positive, women at-risk should be further evaluated for Bladder Cancer by a uro-gynecologist or urologist."
Hematuria is the most frequent symptom of Bladder Cancer. "Of all the Bladder Cancer symptoms, hematuria or blood in the urine is very significant," said Dr. Ross. "However, there are many reasons for hematuria, more for women than for men."
"Often hematuria is a misleading symptom, one which women tend to ignore," adds Dr. Katz. "This may explain why a greater percentage of women are diagnosed at a later stage of the disease. Hematuria can be intermittent and its degree does not correlate with the severity of the cancer. Unfortunately, that may contribute to the higher mortality rates for women."
In this investigation, all the women diagnosed with bladder malignancy had hematuria. The American Urological Association (AUA) Best Practice Policy recommends that high risk patients with hematuria undergo an evaluation for Bladder Cancer even after a single episode.
Dr. Katz, a principal investigator in two large multisite clinical trials evaluating hematuria and Bladder Cancer detection said, "Women with a history of smoking, environmental or occupational exposure to chemicals, or who present with hematuria or dysuria (painful or difficult urination) and are negative for urinary tract infection should be considered for evaluation of Bladder Cancer." He added, "We need to educate both our patients and their physicians about this cancer and use the best tools we have to diagnose them early. The NMP22 BladderChek Test helps us focus our search earlier, expediting our diagnosis and adding a measure of confidence for the physician in determining the cause of the hematuria. I use it in my practice because it is an easy to use noninvasive urine test that provides a result while my patient is in the office. It's proven to increase the detection of cancer, and it's half the cost of laboratory tests."
Dr. Ross also noted that many women who are otherwise conscientious about their health are unaware about the prevalence and impact Bladder Cancer can have on their lives. According to the National Institutes of Health (NIH) SEER data, Bladder Cancer is almost as prevalent in women as ovarian and cervical cancers. Bladder Cancer also has the highest recurrence rate of any cancer.
This year's SGI annual meeting focused on gender and ethnic disparities. The disparity between women and men in both the diagnosis of Bladder Cancer and five year survival rates is compelling. Bladder Cancer occurs more frequently in men than women, but women have a disproportionately higher death rate. There is a higher percentage of men who survive for ten years after diagnosis than women who survive for five. However, the five year survival rate for Bladder Cancer is 92% in women if tumors are detected while they are still confined in the bladder lining, but drops to 43% or less once they become invasive. Also, there is growing evidence that when smoking factors are comparable, the risk of Bladder Cancer in women may be higher than that in men.
Cigarette smoking is the most common risk factor and doubles the risk of Bladder Cancer. In fact, smoking accounts for 30% of Bladder Cancer deaths in women. Occupations that involve organic chemicals and dyes, such as beautician, dry cleaner, painter, paper production worker, rope and twine industry worker have been reported to increase risks. Other industrial exposures implicated as risk factors for developing Bladder Cancer include combustion gases and soot from coal, chlorinated aliphatic hydrocarbons, and chlorination by-products in heated water. The other associated occupations to these risk factors include firefighter, truck driver, plumber, leather and apparel worker, autoworker, and rubber and metal workers.
About the NMP22® BladderChek® Test
The NMP22® BladderChek® Test was developed and commercialized by Matritech, a leading developer 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 protein marker levels, even at early stages of the disease. A study published in the Journal of the American Medical Association (JAMA) in January, 2006 demonstrated that the NMP22 BladderChek Test used in combination with cystoscopy (a visual examination of the bladder), detected 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.
The NMP22® BladderChek® Test, a painless and noninvasive assay, is the only in-office test approved by the FDA for the diagnosis of Bladder Cancer. The BladderChek® Test, which is reimbursed by Medicare and other medical insurers, is more cost effective than cell-based laboratory cytology tests. It is approved for use in a physician's office with results available in 30 minutes - during the patient visit, allowing a rapid, accurate and cost-effective way to aid in the detection of Bladder Cancer.
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 more than 15 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 these 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.
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