Healthcare Industry News: Bladder Cancer
News Release - May 22, 2006
Matritech's NMP22(R) BladderChek(R) Test Could Save Lives and Reduce Expense in Screening High Risk Populations for Bladder CancerIndependent Study from University of Texas Southwestern Reports NMP22(R) BladderChek(R) Test could be Beneficial for Detecting Cancer Earlier in High Risk Populations
NEWTON, Mass.--(HSMN NewsFeed)--May 22, 2006--Matritech (Amex: MZT ), a leading developer and marketer of protein-based diagnostic products for the early detection of cancer, announced today that independent investigators have reported that certain tests, such as the NMP22® BladderChek® Test, could save lives and reduce expense when screening high risk populations for Bladder Cancer.
Yair Lotan, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center, assessed the cost-effectiveness and lives saved from screening for Bladder Cancer in high risk populations. Included in his analysis were factors influencing the effectiveness of cancer screening, including survival benefit, disease prevalence, screening efficacy, and cost. He found that tests such as the NMP22 BladderChek Test could save lives and reduce expense. All other cancer screening programs save lives but increase expense. Dr. Lotan presented his findings today at the American Urology Association (AUA) annual meeting.
"While the goal of cancer screening is to detect cancer early and save lives, it must be reasonably cost-effective if it is to be instituted widely. With the FDA approval of the NMP22 Test for diagnosing high risk patients, the healthcare community has an initial test that could be assessed for efficacy in screening," commented Dr. Lotan.
Dr. Lotan and his colleagues created a decision analysis model to estimate the five year cumulative cancer-related costs and efficacy of screening (versus not screening) a high-risk population for Bladder Cancer using a urine-based tumor marker, such as the NMP22 BladderChek Test. High risk was designated as over 50 years of age with a heavy smoking history and/or significant occupational exposure to toxins and dyes.
"This study goes beyond analyzing the cost of cancer detected. It is about the cost per life saved and defines how effective a urine marker needs to be to perform as a screening tool. In the absence of screening, one in four cancers is detected when it is already advanced, requiring expensive treatment and reduced survival. Screening offers the potential for detecting cancers earlier, resulting in less invasive and less costly treatments, as well as improved survival," he explained.
The analysis indicated urine-based Bladder Cancer markers could reduce mortality and save costs in a high-risk population, if the cost of the urine test is less than $126. Overall the Lotan model projected a gain of three life years and $101,000 saved from reduced treatment costs per 1,000 people screened based on a population with 4% incidence of Bladder Cancer. Researchers noted that adjusting for other causes of mortality did not vary the results significantly, and screening versus not screening is more cost-effective as long as the cancer incidence is greater than 1.6%.
In a previous study of the cost per cancer detected in a high risk population, Dr. Lotan found the use of the NMP22 BladderChek Test would be about $3,310, assuming a cancer incidence of about 6% per year, making it similar or superior to screening for prostate, breast and colon cancer. His analysis showed that for women undergoing mammography screening, the cost per breast cancer detected can be as high as $14,000. Prostate cancer screening with PSA leads to costs of nearly $3,000 per cancer detected; colorectal cancer screening has a broader range of $2,000-$5,000 per cancer detected.
Bladder Cancer has the highest cost per patient of all cancers from diagnosis to death. In the United States alone, it is estimated that the annual direct costs of Bladder Cancer management are $4 billion. According to 2005 SEER data from the National Institutes of Health (NIH), Bladder Cancer is more common and has a higher mortality than cervical cancer. It is almost as common in men as colon cancer.
Dr. Lotan suggests that Bladder Cancer is an ideal disease for screening a high risk population because the risk factors are well known. "The best possibility for reducing Bladder Cancer mortality is early detection," he emphasized. "One out of four bladder malignancies are currently diagnosed at an advanced stage. Bladder tumors detected early when they are non-muscle invasive are very treatable, and the five-year survival rate is 95%. However, once the tumors become more advanced the survival rate drops steadily from 50% to 10%."
Implementation of a screening strategy, however, requires a prospective, randomized trial to assess both the detection-accuracy of these markers in asymptomatic individuals and the impact of screening on cancer-specific mortality. Dr. Lotan hopes this model will help healthcare professionals identify at risk populations that would benefit from Bladder Cancer screening.
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 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 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 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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