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Back To Vidyya Proof of 'Clinical Concept' for Breast Cancer Blood Test is Complete

All Cases of Breast Cancer Were Detected By New Test

Matritech, Inc. (NASDAQ: NMPS), a company specializing in products designed to detect, manage and screen for cancer, today announced that it has completed the 'proof of clinical concept' of its proprietary NMP66 blood test for women with, or at risk of, breast cancer. The NMP66 test is based on the Company's nuclear matrix protein (NMP) technology platform, which correlates levels of NMPs in body fluids to the presence of cancer.

Led by Matritech scientist Brynmor Watkins, Ph.D., 78 specimens have been tested using Matritech's proprietary specimen preparation and mass spectrometry procedures. 45 of these specimens came from women diagnosed with breast cancer in various stages of the disease and 5 were from women with Ductal Carcinoma In Situ (DCIS), a condition that can progress to cancer. An additional 28 specimens came from women who were normal or had been diagnosed as having benign disease. NMP66 was found in the blood of every woman who was diagnosed with cancer and was absent in all of the 'normal' specimens.


The results of the NMP66 testing are as follows:

Advanced metastatic disease 21 out of 21 detected

Newly diagnosed metastatic disease 5 out of 5 detected

Greater than 1 lymph node involved 8 out of 8 detected

1 lymph node involved 6 out of 6 detected

No lymph nodes involved 5 out of 5 detected

DCIS 4 out of 5 detected

Normal and benign disease 26 out of 28 ruled out 


"We are extremely encouraged by the accuracy of our breast cancer markers during this proof of clinical concept testing," said David L. Corbet, President and Chief Operating Officer of Matritech. "We detected every case of cancer, and ruled out cancer for all normal samples. Based on this impressive accuracy, we consider 'proof of concept' complete."

 "When breast cancer is discovered at its earliest stage, the five-year survival rate is well over 90 percent," added Corbet. "Further testing and development of this breast cancer blood test is therefore a high priority for Matritech going forward."

"The current standard of care, mammography, can miss cancers, especially in younger women. In addition, since women who undergo the procedure often report discomfort, many others do not bother to be tested at all," said Melodie Domurad, Ph.D., vice president of clinical and regulatory affairs at Matritech. "Further, because mammograms are subject to interpretation, there exists the possibility of error. We believe that the clinical value of NMP66, as an additional method to detect and manage the treatment of women with breast cancer, is enormous."

"If a test with high sensitivity and specificity levels, like the NMP66, were developed, patient management would be significantly enhanced through earlier cancer detection, leading to fewer deaths," said Dr. Margaret Kemeny, chief of surgical oncology and executive medical director of the Carol M. Baldwin Breast Care Center at the State University of New York, Stony Brook.

The NMP66 test kit will be protected by claims contained in three patents issued to the Massachusetts Institute of Technology and licensed exclusively to Matritech. The Company recently filed four additional patents claiming the use of this, and other NMPs, in the management of women with breast cancer.

Matritech scientists determined the identity and partial amino sequence of NMP66. It is a member of a class of NMPs that regulate the splicing of pre-mRNA, a critical event in the development of all eukaryotic cells, including those that progress to become malignant.

Matritech's nuclear matrix protein (NMP) core technology correlates levels of NMPs in body fluids to the presence of cancer. Multiple published clinical studies have validated this ability of NMPs to detect early-stage cancerous abnormalities. Matritech has a deep pipeline of NMP-based products in pre-clinical and clinical development for the detection of major cancers including bladder, cervical, breast, prostate and colon cancers. The NMP22 Test Kit is cleared for marketing in the United States for management and screening of individuals at risk of bladder cancer. It is also sold in Europe and Japan, where it is approved for bladder cancer screening.

Matritech Inc., based in Newton, Mass., is using its proprietary nuclear matrix protein (NMP) technology, discovered at the Massachusetts Institute of Technology, and licensed exclusively to Matritech, to develop and commercialize innovative serum-, cell- and urine-based NMP diagnostics that enable physicians to reliably detect and monitor the presence of bladder, cervical, breast, prostate and colon cancers.

Statement Under the Private Securities Litigation Reform Act

Any forward-looking statements related to the Company's expectations regarding the performance, market acceptance, future sales and regulatory approvals of the Company's existing and future products and potential arrangements with marketing partners 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 the Company’s limited capital resources, the Company's ability to consummate marketing partnerships on terms acceptable to it, unforeseen delays in or denials of 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 assurances that the Company's expectations for its products will be achieved.

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Editor: Susan K. Boyer, RN
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