Matritech's NMP22 BladderChek Test Detects Bladder Cancer Missed by Conventional Laboratory Test; Independent Studies Presented at European Association of Urology Meeting.Business Editors/Health/Medical Writers BIOWIRE2K NEWTON, Mass.--(BUSINESS WIRE)--March 23, 2004 Matritech (AMEX: MZT MZT - Mazatlan, Sinaloa, Mexico - Buelna (Airport Code)), a leading developer of proteomics-based diagnostic products for the early detection of cancer, today announced the presentation of results of three independent clinical studies involving its NMP22 Bladder Cancer product line at the XIXth Congress of the European Association of Urology (EAU), being held in Vienna, Austria. Two urology groups presented data demonstrating the utility of the NMP22(R) BladderChek(R) Test for monitoring and diagnosis of bladder cancer, and one additional presentation reported that the high negative predictive value of the NMP22(R) protein could make it suitable as a screening tool. Dr. Peter Oehr of the University of Bonn reported the results of using the NMP22 BladderChek Test for initial diagnosis of patients who presented with hematuria endemic hematuria urinary schistosomiasis. essential hematuria that for which no cause has been determined. false hematuria pseudohematuria. renal hematuria that in which the blood comes from the kidney. (blood in the urine). The study included 212 hematuria patients at 16 urologists' offices, of whom 113 also had cytology aspiration biopsy cytology (ABC) the microscopic study of cells obtained from superficial or internal lesions by suction through a fine needle. exfoliative cytology microscopic examination of cells desquamated from a body surface or lesion as a means of detecting malignancy and microbiologic changes, to measure hormonal levels, etc. Such cells are obtained by aspiration, washing, smear, or scraping. performed. The NMP22 BladderChek Test detected 82% of the bladder cancers compared to only 57% found by cytology, thereby demonstrating that the NMP22 BladderChek Test is more accurate than cytology at identifying patients with bladder tumors. Both tests ruled out 97% of the patients without cancer. The study also confirmed that the presence of blood in the urine did not interfere with the NMP22 BladderChek Test results. "The results of Dr. Oehr's study confirm the superior ability of the NMP22 BladderChek Test to identify bladder tumors compared to cytology. In addition to detecting cancers missed by cytology, the NMP22 BladderChek Test delivers a much faster result," stated David L. Corbet, President and Chief Operating Officer of Matritech, Inc. "At Matritech, it is our mission to provide physicians with the most accurate and convenient diagnostic tools for the best management of their patients." A second investigation presented at the EAU meeting demonstrated that the NMP22 BladderChek Test is clinically useful for monitoring patients who have undergone a common treatment for bladder cancer called BCG. This study, conducted at the University of Barcelona in Spain, monitored 23 patients during their first evaluation following treatment with BCG. The NMP22 BladderChek Test showed no interference from the immunotherapy, and correctly identified 93% of the patients who were free of cancer, demonstrating that it is a very effective tool for managing patients following treatment with BCG. In the third study, Dr. Gerson Ludecke at the University of Giessen Giessen (gē`sən), city (1994 pop. 73,705), Hesse, central Germany, on the Lahn River. It is an industrial center and rail junction. Its manufactures include machinery, textiles, rubber goods, and tobacco products. Iron ore is mined nearby. Giessen was chartered by 1248 and became the chief town of Upper Hesse. in Germany reported that NMP22 protein would be suitable as a screening marker for bladder cancer in defined risk populations based on the product's excellent performance identifying patients without bladder cancer. Dr. Ludecke reviewed NMP22 values from 517 patients with a variety of urological cancers and other urinary tract disorders and 39 volunteers as controls. NMP22 was accurately negative in 92% of both the control group and patients with urological malignancies other than of the bladder, and detected 75% of the bladder tumors. About NMP22(R) BladderChek(R) Test The NMP22 BladderChek Test is the only in-office test approved by the FDA for the diagnosis of bladder cancer. The NMP22 BladderChek Test is a painless and non-invasive assay, performed on a single urine sample, that detects elevated levels of NMP22 protein. Healthy individuals generally have very small amounts of NMP22 protein in the urine. However, the level of NMP22 protein is often elevated in the urine of patients with bladder cancer, even at early stages of the disease. The test can be performed in a physician's office with results delivered during the patient visit, allowing for a rapid, accurate and cost-effective way to aid in the detection of bladder cancer in patients at risk. NMP22 protein has been FDA-approved four times for various formats and claims, most recently in April 2003 for point-of-care use for diagnosis. 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(R) Test Kit and NMP22(R) BladderChek(R) Test, have been approved for the monitoring and diagnosis of bladder cancer. The NMP22 BladderChek Test is based on Matritech's proprietary nuclear matrix protein (NMP) technology, exclusively licensed from the Massachusetts Institute of Technology, which correlates levels of NMPs in body fluids to the presence of cancer. The Company has discovered other proteins associated with cervical, prostate, breast and colon cancer and is, with its own research staff and through strategic alliances, in various stages of development targeted to each of these applications. More information about Matritech is available at www.matritech.com. Statement Under the Private Securities Litigation Reform Act Any forward-looking statements related to the Company's expectations regarding its current and future products, business prospects, and the results of operations or financial position, expected financial performance and expected customer sales are subject to a number of risks and uncertainties, many of which are beyond the Company's control. These include but are not limited to, risks related to unforeseen technical obstacles in completing development of new products, unforeseen delays in, or denials of, FDA and other regulatory approvals, future product demand and pricing, performance of distributors and partners, the timing of orders from distributors, competitive products and technical developments, general business and economic conditions and those other risk factors described 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 or future financial performance 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 update any such forward-looking information. |
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