Healthcare Industry News: Rochester Medical
News Release - May 24, 2006
Studies Presented at American Urological Association Expand the Role of the NMP22(R) BladderChek(R) TestImproves Bladder Cancer Detection to 99% - Aiding the Earlier Detection of Cancer
Reported to Indicate Likelihood of Life Threatening Bladder Malignancy
Recommended for use in Screening High Risk Populations for Bladder Cancer to Save Lives and Reduce Expense
4 Times More Effective than the Conventional Laboratory Urine Test in Detecting Recurrent Bladder Cancer
NEWTON, Mass.--(HSMN NewsFeed)--May 24, 2006--Matritech (Amex: MZT ) reported today that independent clinical investigators recommended the NMP22® BladderChek® Test be included in standard practice for diagnosing and monitoring bladder cancer. The test was featured and included in a number of presentations, which highlighted the clinical utility of the point-of-care urine diagnostic test in bladder cancer diagnosis, monitoring and screening, at this year's 101st Annual Meeting of the American Urological Association (AUA) in Atlanta.
"The presentations, and particularly the support from these highly respected clinicians, have delivered a compelling message about the benefits the NMP22 BladderChek Test can provide in standard practice from diagnosing and monitoring bladder cancer to its potential for saving lives and expense in screening people who are at risk for the cancer," said Stephen D. Chubb, Chairman and CEO of Matritech.
Highlights from the NMP22 BladderChek Test presentations included:
- when used in combination with cystoscopy significantly improved the detection of recurring bladder cancer to 99%;
- was positive for 8 of 9 cancers not seen by cystoscopy, including seven tumors that were aggressive or advanced;
- detected four times as many cancers as the laboratory based urine cytology test; is the only urine test shown to indicate whether a bladder malignancy is likely to be dangerous;
- has the potential to save lives and reduce expense in screening high risk populations for bladder cancer - all other cancer screening programs save lives but increase expense.
Bladder cancer diagnosis and monitoring data were presented by three U.S. urologists, regarded as authorities in bladder cancer research and clinical care:
- H. Barton Grossman, M.D., Deputy Chairman, Department of Urology, M.D. Anderson Cancer Center, Houston, TX
- Mark Soloway, M.D., Chairman of the Department of Urology at the University of Miami Leonard M. Miller School of Medicine
- Barry Stein, M.D., Surgeon-in-Chief of Urology, Rhode Island Hospital and Professor of Urology, Brown Medical School
New information about the cost effectiveness and life years saved by including bladder cancer screening into mainstream medical care was presented by:
- Yair Lotan, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center
The ability of a screening program to reduce bladder cancer mortality was emphasized in another podium presentation by Edward Messing, M. D., Chairman of the Urology Department, University of Rochester Medical Center, also an author of the two published JAMA reports on the NMP22 BladderChek Test. His long term follow up of patients screened for bladder cancer demonstrated that overall mortality was significantly lower in bladder cancer patients diagnosed by early screening (43%) vs. those whose disease was not detected by early screening (74 %). Screening allowed more cancers to be found early, thereby decreasing the number of bladder-cancer mortalities over time in this group. This presentation was included in a plenary session.
The NMP22 BladderChek Test is not meant to replace cystoscopy (a visual examination of the inside of the bladder with a lighted scope), an examination often considered the "gold standard" for diagnosing bladder cancer. Every NMP22 BladderChek Test result, however, provides clinically useful information when used in combination with cystoscopy. It is also the only urine test approved by the FDA (by prescription) for home use as an aid in diagnosing bladder cancer.
Dr. Soloway commented, "Using the NMP22 BladderChek Test with cystoscopy adds useful information to enhance our ability to detect and treat a cancer. Cystoscopy is very good, but not perfect--that's why physicians use adjunctive tests."
Dr. Grossman also said, "The combination of the NMP22 test with cystoscopy detected significantly more cancers than cystoscopy alone. Adding the NMP22 test improved detection. Moreover, it's easy to use in an office setting, provides an answer in half an hour, and is inexpensive."
Other discussions of the NMP22® BladderChek® Test included an overview by Dr. Grossman in a continuing medical education program (CME), Bladder Cancer: Practical Considerations in the Use of Markers, A Case-based Symposium. In his introduction to this course, which was intended to keep physicians up to date on the uses of tumor markers, he pointed out that the NMP22 BladderChek Test was proven to identify cancers missed by cystoscopy in two large clinical trials, citing the publications in JAMA. He also emphasized that when using any diagnostic test it is important to understand its performance characteristics. As an example, he compared the NMP22 BladderChek Test to a common laboratory analysis, urine cytology. Dr. Grossman drew attention to the significantly better negative predictive value (NPV), or reliability of a negative test result, of the point-of-care test, which has fewer missed cancers (false negatives).
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 protein 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 other 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 (a visual examination of the interior of the bladder using a scope inserted through the urethra), in the diagnosing 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 the NMP22 BladderChek Test 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. The test was also reported to detect all of the 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.
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.
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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