I know it's a day late and everyone's probably already seen it, but too much good info in here to pass up :
Matritech Submits 510(K) Premarket Notification To
FDA For Clearance of Blood Based Colon Cancer Test
NuMA(TM) Test Kit is Company's Second Cancer Test Based on Nuclear
Matrix Protein Technology
NEWTON, Mass., Oct. 16 /PRNewswire/ -- Matritech, Inc. (Nasdaq:NMPS) has submitted a 510(k) Premarket Notification to the FDA for clearance of its blood-based NuMA(TM) Test Kit to aid in the management of colon cancer patients, the Company announced today. The test is the second clinical diagnostic product based on the Company's Nuclear Matrix Protein (NMP) technology and correlates levels of NMPs in body fluids to the presence of cancer.
''This filing, based on over 1,000 clinical trial samples, demonstrates the improved level of sensitivity that NuMA provides in detecting colon cancer and underscores the potential of our core
technology and our ability to apply it to develop and commercialize innovative tests for a broad range of major cancers,'' said David L. Corbet, Matritech's President. ''With this submission, the Company has met a key corporate milestone for the year. We remain on schedule to begin clinical trials for NMP-based cervical and breast cancer tests, as well, '' he continued.
Clinical blood specimens used in the trial were obtained from patients with Dukes stages ''B'' and ''C'' (intermediate) colon tumors to compare levels of NuMA in their blood before, during and after therapy. NuMA is an NMP, which has been shown to be present in significantly elevated levels in colon cancer cells. In addition, these results were compared to results from individuals with no
cancer history, patients with malignant diseases other than colon cancer, and patients with other disorders of the digestive system. The present FDA approved test used in the management of colon cancer patients is carcino-embryonic antigen (CEA). Matritech's clinical trial also included a comparison of its NuMA(TM) Test Kit to CEA. In this clinical trial, the sensitivity of the NuMA(TM) Test Kit was greater than that of CEA for both the Dukes ''B'' and ''C'' pre-surgery patients. The Premarket Notification for the Test Kit has been filed in accordance with section 510(k) of the Federal Food, Drug and Cosmetic Act, in response to the recent FDA reclassification of certain uses of tumor markers.
Colon cancer is the fourth most common cancer in the US 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. Present methods of colon cancer patient management include surgery, radiation and anti-tumor drugs. Patients are monitored for recurrence of disease using CEA, although its overall sensitivity has been reported to be less than 50 percent and it is not useful for approximately 25 percent of colon cancer patients who do not exhibit elevated levels of the CEA antigen. Worldwide sales of CEA are estimated to exceed $100 million.
All of Matritech's diagnostic assays are based on a fundamental breakthrough in cell biology discovered at the Massachusetts Institute of Technology (MIT), where researchers found that nuclear matrix proteins in cancer cells differ from those in normal cells. MIT obtained three patents covering the use of NMPs to detect cancer, and has licensed their discovery exclusively to Matritech. Those patents are enabling the biotechnology firm to develop accurate detection and
monitoring tests for cancer. In addition to the bladder and colon assays already in Matritech's pipeline, are products for detecting cervical, breast and prostate cancers -- all of which are based
on discoveries that the protein composition of the nuclear matrix differs between cancer cells and normal cells.
Matritech, Inc., based in Newton, MA, is using its proprietary NMP technology, discovered at 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, breast, cervical, colorectal and prostate cancers.
Any forward-looking statements related to the Company's expectations regarding 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 unforeseen delays in FDA and other regulatory approvals, future product demand and pricing, performance of distributors, competitive products, and technological
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. |
