|Proof of 'Clinical Concept' for Breast Cancer Blood Test is Complete
All Cases of Breast Cancer Were Detected By New Test
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
"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.
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health care reform and general business and economic conditions.
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its products will be achieved.