Study Shows Matritech's New Test (NMP179) May Reduce Uncertainty,
Apprehension and Cost Associated With Millions Of Mildly Abnormal Pap
Smears (ASCUS)
PR Newswire - November 04, 1998 08:25
Findings Being Presented at Annual Meeting of the American Society of Cytopathology (ASC)
NEWTON, Mass., Nov. 4 /PRNewswire/ -- NMP179, a diagnostic assay developed by Matritech, Inc. (Nasdaq: NMPS), has been
shown -- in a limited study of patients whose Pap smears had initially been reported as mildly abnormal or ASCUS - (atypical
squamous cells of undetermined significance) -- to be highly effective in predicting the likelihood that an ASCUS-stage Pap smear
will or will not progress to more advanced disease.
The study was conducted to test the hypothesis that colposcopy referrals could be reduced with the use of NMP179 immunoassay.
Data from the study, which are being presented at the annual meeting of the American Society of Cytopathology (ASC), shows that
the NMP179 immunoassay was 92 percent sensitive in predicting the development of cervical dysplasia after a Pap smear registered
as ASCUS. NMP179 also had a specificity of 73 percent, a positive predictive value of 73 percent, and a negative predictive value of
92 percent.
"NMP179 may be a cost-effective tool for the triage and management of women with Pap smears categorized as ASCUS," said
Martha Hutchinson, Ph.D., M.D., Director of Cytopathology at Women and Infants Hospital in Providence, R.I. "While only a small
percentage of individuals with Pap smears categorized as ASCUS develop cervical cancer over time, until now it has been impossible
to identify which of those gray zone patients are at high risk, a situation that results in an unacceptably high proportion of repeat
cytologies and colposcopy referrals. The annual cost of these referrals -- the overwhelming number of which are unnecessary -- is
estimated at more than $3.6 billion in the United States alone."
"An ASCUS-stage result occurs in approximately 2.5 - 5 million of the 50 million Pap smears that are performed annually in the
United States," said David L. Corbet, President and Chief Operating Officer of Matritech. "The majority of those women are referred
for a colposcopy, an invasive and expensive procedure whereby a sample of the cervix is removed for further examination. With the
American Cancer Society reporting only 14,700 new cases of cervical cancer this year in the United States, millions of women are
subjected to colposcopies that are unnecessary. Using NMP179 to rule out truly low-risk individuals could improve the quality of life
for those women as well as significantly reduce the $3.6 billion annual cost of unnecessary ASCUS follow-up."
Matritech's nuclear matrix protein (NMP) technology platform 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,
colon, cervical, breast and prostate cancers. The NMP22(R) Test Kit is approved in the United States, Europe and Japan for the
management of patients with transitional cell carcinoma of the urinary tract. It is the only approved kit for bladder cancer screening in
Japan.
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, colon, cervical, breast
and prostate cancers.
Statement Under the Private Securities Litigation Reform Act
Any forward looking statements related to the Company's expectations regarding the performance, cost, benefits, market acceptance,
future sales and regulatory approvals 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 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.
SOURCE Matritech, Inc.
/CONTACT: Stephen D. Chubb, CEO of David L. Corbet, President of
Matritech, Inc., 617-928-0820 or Derek Caldwell of Sunrise Financial Group,
212-421-1616 or Steve Danehy, Associate or Jon Siegal, Associate of
Ronald Trahan Associates, Inc., 617-332-0101/
(NMPS) be highly effective in predicting the likelihood that an ASCUS-stage Pap smear
will or will not progress to more advanced disease.
The study was conducted to test the hypothesis that colposcopy referrals could be reduced with the use of NMP179 immunoassay.
Data from the study, which are being presented at the annual meeting of the American Society of Cytopathology (ASC), shows that
the NMP179 immunoassay was 92 percent sensitive in predicting the development of cervical dysplasia after a Pap smear registered
as ASCUS. NMP179 also had a specificity of 73 percent, a positive predictive value of 73 percent, and a negative predictive value of
92 percent.
"NMP179 may be a cost-effective tool for the triage and management of women with Pap smears categorized as ASCUS," said
Martha Hutchinson, Ph.D., M.D., Director of Cytopathology at Women and Infants Hospital in Providence, R.I. "While only a small
percentage of individuals with Pap smears categorized as ASCUS develop cervical cancer over time, until now it has been impossible
to identify which of those gray zone patients are at high risk, a situation that results in an unacceptably high proportion of repeat
cytologies and colposcopy referrals. The annual cost of these referrals -- the overwhelming number of which are unnecessary -- is
estimated at more than $3.6 billion in the United States alone."
"An ASCUS-stage result occurs in approximately 2.5 - 5 million of the 50 million Pap smears that are performed annually in the
United States," said David L. Corbet, President and Chief Operating Officer of Matritech. "The majority of those women are referred
for a colposcopy, an invasive and expensive procedure whereby a sample of the cervix is removed for further examination. With the
American Cancer Society reporting only 14,700 new cases of cervical cancer this year in the United States, millions of women are
subjected to colposcopies that are unnecessary. Using NMP179 to rule out truly low-risk individuals could improve the quality of life
for those women as well as significantly reduce the $3.6 billion annual cost of unnecessary ASCUS follow-up."
Matritech's nuclear matrix protein (NMP) technology platform 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,
colon, cervical, breast and prostate cancers. The NMP22(R) Test Kit is approved in the United States, Europe and Japan for the
management of patients with transitional cell carcinoma of the urinary tract. It is the only approved kit for bladder cancer screening in
Japan.
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, colon, cervical, breast
and prostate cancers.
Statement Under the Private Securities Litigation Reform Act
Any forward looking statements related to the Company's expectations regarding the performance, cost, benefits, market acceptance,
future sales and regulatory approvals 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 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.
SOURCE Matritech, Inc.
/CONTACT: Stephen D. Chubb, CEO of David L. Corbet, President of
Matritech, Inc., 617-928-0820 or Derek Caldwell of Sunrise Financial Group,
212-421-1616 or Steve Danehy, Associate or Jon Siegal, Associate of
Ronald Trahan Associates, Inc., 617-332-0101/
(NMPS) |
