To: John McCarthy who wrote (581 ) 2/25/1998 3:32:00 PM From: Damon Pham Read Replies (1) | Respond to of 849
Matritech Researchers Present Comparative Data on NuMA Colon Cancer Test at the Joint American Association of Cancer Research, Japan Cancer Association NEWTON, Mass., Feb. 25 /PRNewswire/ -- Matritech, Inc. (Nasdaq: NMPS - news) announced today that researchers recently presented data demonstrating the clinical performance of its NuMA(TM) Test Kit for colon cancer at the joint conference of the American Association of Cancer Research and the Japan Cancer Association. The presentation described data comparing the sensitivity of the NuMA test and carcino-embryonic antigen (CEA) test in detecting early-stage colon cancer. The data presented was also included in Matritech's 510(k) submission filed with the FDA this past October for NuMA for the management of colon cancer patients. NuMA is based on the Company's Nuclear Matrix Protein (NMP) technology, and correlates levels of NMPs in body fluids to the presence of cancer. The data announced today represent the comparative portion of the 510(k) submission to the FDA, which in total included an evaluation of 1200 clinical blood specimens from subjects with colon tumors, other malignant disease, benign gastro-intestinal disease, and risk factors for colon cancer and normal, healthy individuals. The study results presented at the conference were derived from a blinded comparative evaluation of banked specimens that analyzed the blood sera of 85 patients, predominantly Dukes stages ''B'' and ''C'', to compare the performance of NuMA and CEA. ''When employing reference values determined by Receiver Operator Characteristic analysis, NuMA had better sensitivity than CEA for early-stage colon cancer,'' said Dr. Joseph Briggman, Matritech's Immunoassay and Cellular Systems Director and lead researcher on the study. ''For colon cancer Dukes ''B'' stage subjects, NuMA and CEA had sensitivities of 47% and 20%, respectively, and for the Dukes ''C'' subjects, the sensitivities were 48% and 38%, respectively. In this study, specificity of each test in normal individuals was 84% for NuMA and 86% for CEA. Although the specificity of CEA for benign conditions of the colon was superior, NuMA was more sensitive to familial adenomatous polyposis (FAP) believed to be a cancer precursor.'' The Receiver Operator Character analysis is a standard tool used for evaluating a test's performance. ''Our NMP-based products represent a new generation of cancer tumor markers,'' said David Corbet, President of Matritech, ''This study underscores the potential of our core technology.'' Colon cancer is the fourth most common cancer in the U.S. and is the second most common cause of deaths from cancer. Although the reported mortality for the disease is 40 percent for patients diagnosed in the later stages, mortality for those individuals diagnosed at earlier stages is 10 percent. Matritech, Inc., based in Newton, M.A., is using its proprietary NMP technology, discovered at the Massachusetts Institute of Technology (MIT) and licensed exclusively to Matritech, to develop and commercialize innovative serum-, cell- and urine-based diagnostics that enable physicians to reliably detect and monitor the presence of bladder, colon, cervical, breast, and prostate cancer. Any forward-looking statements related to the Company's expectations regarding the performance, benefits to patients, market acceptance and future sales of the Company's existing and future products 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 incorrect use of products by customers, unforeseen delays in FDA and other regulatory approvals, future product demand and pricing, performance of distributors, competitive products, and technical developments, health care reform and general business and economic conditions. There can be no assurance that the Company's expectations for its product will be achieved. SOURCE: Matritech, Inc.