NEWTON, Mass., July 8 (Reuter) - Matritech Inc said Monday its NMP22 Test
Kit has been approved for sale in the U.S. by the Food and Drug
Administration for use in identifying patients at risk for recurrence of
bladder cancer.
The test kit is the first Nuclear Matrix Protein based diagnostic product
to be approved by the FDA, Matritech said.
"We expect that Nuclear Matrix Proteins will become recognized as
practical and reliable cancer markers, applicable to most, if not all, forms
of cancer," it said.
The kit, in a separate study, was found to be twice as sensitive as urine
cytology. The test is a painless, low-cost and quantitative tool for the
prognosis of transitional cell carcinoma of the urinary tract, which accounts
for more than 90 percent of bladder cancer, the company said.
Donald Lamm, M.D., chairman of the Department of Urology at West Virginia
University, expects that Matritech's urine assay for bladder cancer will make
a "very considerable contribution"
to improving the care of patients monitored regularly for the recurrence of
bladder cancer.
"NMP220 identifies patients who are at increased risk for tumor
recurrence and will allow the doctor to better tailor follow-up to individual
patients," said Lamm. "We may be able to safely delay and reduce the number
of cystoscopies needed, therefore reducing both expense and discomfort."
-- New York Newsdesk 212-859-1610.
09:49 07-08-96
First Nuclear Matrix Protein (NMP)-Based Cancer Detection Test is First
Urology Major Cancer Marker to Get FDA Approval Since PSA 10 Years Ago
NEWTON, Mass., July 8 /PRNewswire/ -- Matritech Inc. (Nasdaq: NMPS; BSE: MPS)
announced today that the company's Matritech NMP22(R) Test Kit has been
approved for sale in the U.S. by the Food and Drug Administration (FDA) for
use in identifying patients at risk for recurrence of bladder cancer. The
Matritech NMP22 Test Kit is the first Nuclear Matrix Protein (NMP)-based
diagnostic product to be approved by the FDA for sale in the United States.
"We expect that our first NMP-based test, for bladder cancer, will make a
major contribution to improved patient care for the estimated half a million
U.S. residents who are monitored regularly for recurrence of bladder cancer,"
said David L. Corbet, president of Matritech. "Additionally, we expect that
Nuclear Matrix Proteins will become recognized as practical and reliable
cancer markers, applicable to most, if not all, forms of cancer," concluded
Corbet.
The Matritech NMP22 Test Kit, in a separate study, was found to be twice as
sensitive as urine cytology. The test is a painless, low-cost and
quantitative tool for the prognosis of transitional cell carcinoma (TCC) of
the urinary tract, which accounts for more than 90 percent of bladder cancer.
Donald Lamm, M.D., chairman of the Department of Urology at West Virginia
University and one of the world's leading authorities on bladder cancer,
expects that Matritech's urine assay for bladder cancer will make a "very
considerable contribution" to improving the care of patients monitored
regularly for the recurrence of bladder cancer.
"NMP220 identifies patients who are at increased risk for tumor recurrence
and will allow the doctor to better tailor follow-up to individual patients,"
said Dr. Lamm. "We may be able to safely delay and reduce the number of
cystoscopies needed, therefore reducing both expense and discomfort."
Added Daniel B. Rukstalis, M.D, chief of urology at Medical College of
Pennsylvania, who also participated in clinical trials of NMP22: "A low
NMP22 value ten days after surgery enables near-90 percent certainty that my
patient will not have a malignancy at his or her three-month follow-up visit.
In that case, I can decide to spare my patient the expense, the discomfort,
the uncertainty and the risk of infection associated with cystoscopy.
Conversely, an elevated NMP22 value ten days after surgery gives me a high
degree of certainty that my patient likely will have a recurrence at the
three-month follow-up cystoscopy, which enables me to react quickly, thereby
improving his or her prognosis."
While Drs. Lamm and Rukstalis anticipate that other urologists will embrace a
more accurate and painless alternative to current testing options, they also
noted that Matritech's urine assay will offer patients significant savings.
For example, patients are charged $300 for the invasive cystoscopy.
Matritech anticipates that the same patient would be charged $50 for the
NMP22 test.
"More than 540,000 patients in the United States and some two million
patients around the world may require treatment for bladder cancer,"
concluded Dr. Lamm. "A non-invasive, quantitative, cost- effective tool to
predict tumor recurrence in those patients is very much needed by all
urologists. NMP22 is that tool."
The Matritech NMP22 Test Kit's enabling technology is based on a fundamental
breakthrough in cell biology discovered at the Massachusetts Institute of
Technology (MIT), where researchers found that Nuclear Matrix Proteins (NMPs)
in cancer cells differ from those in normal cells. MIT obtained patents
covering the use of NMPs to detect cancer and licensed their discovery
worldwide, exclusively, to Matritech.
In addition to the bladder assay, already in Matritech's pipeline are
products for detecting breast, cervical, colorectal 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. The medical
market for those assays is estimated to be more than $1 billion per year --
and, because of MIT's patents, Matritech is expected to have the commercial
Nuclear Matrix market to itself.
CO: Matritech, Inc.
ST: Massachusetts
IN: MTC
SU: PDT
07/08/96 09:28 EDT |
