FDA Clears Matritech's NMP22-R- BladderChek-TM- To Test Patients for Bladder
Cancer in the Doctor's
Office
Business Editors/Health/Medical Writers
BIOWIRE2K
NEWTON, Mass.--(BW HealthWire)--Aug. 1, 2002--
-Point-of-care Test Superior to Cytology
in Detecting Both Early Stage and Life Threatening Bladder Cancer-
Matritech Inc. (NASDAQ: NMPS) announced today that it has received
clearance from the U.S. Food and Drug Administration (FDA) to market
NMP22(R) BladderChek(TM) in the United States. The test was launched
outside the United States last year. BladderChek brings rapid
detection into the urologist's office through the use of proteomics
technology.
Clinical trial results reviewed by the FDA show NMP22 BladderChek,
which looks and works much like a home pregnancy test, is a notable
improvement over the current bladder cancer urine test, cytology.
NMP22 BladderChek detected four times more early stage bladder tumors
and 2.5 times as many, life threatening, high-grade tumors as
cytology.
Physicians are using BladderChek in conjunction with cystoscopy,
the primary clinical procedure used by urologists to visually identify
tumors in the bladder.
"Current testing methods alone do not provide sufficiently high
accuracy for detecting bladder cancer," said Ihor Sawczuk, M.D., chief
of Urologic Oncology at Hackensack University Medical Center.
"Physicians need NMP22 BladderChek to increase their confidence of
detecting patients with bladder cancer. This test gives physicians a
rapid answer, allowing them to make informed decisions concerning the
next step in a patient's care. NMP22 BladderChek and cystoscopy are a
powerful, highly accurate diagnostic combination."
NMP22 BladderChek is simple to use and returns results while the
patient is in the physician's office. By placing four drops of urine
on the BladderChek cassette, a physician is able to detect the
presence of NMP22, a nuclear matrix protein correlated with bladder
cancer. A purple line appears to mark the presence of bladder cancer.
The FDA has cleared NMP22 BladderChek to be used in the United
States for monitoring patients with a history of bladder cancer.
Matritech plans to submit clinical data soon to document clinical
utility in screening patients at risk for bladder cancer. Matritech
expects NMP22 BladderChek will be reimbursed by Medicare and most
private insurers. BladderChek was launched outside the United States
in December 2001.
"This is a significant advancement for bladder cancer patients and
a another example of how proteomics is changing the way cancer is
detected," said Stephen D. Chubb, chairman and CEO of Matritech. "The
earlier physicians can detect cancer, the more effective treatment can
be and the greater the chance of patient survival."
Bladder cancer is the fourth most common cancer among men in the
United States with 56,500 cases diagnosed each year. The incidence of
bladder cancer is three times greater in men than women. Smokers and
certain occupations, including rubber, chemical and leather industry
workers, hairdressers, machinists, metal workers, printers, painters,
textile workers and truck drivers, are at increased risk. If diagnosed
in its early stages, the five-year bladder cancer survival rate
exceeds 90 percent. However, if the cancer reaches an advanced stage,
the five-year survival rate can be less than 10 percent.
Clinical Results
Matritech's clinical trial included 668 individuals from 23 trial
sites in 9 states. In addition to the trial results that showed
increased accuracy over cytology, study findings showed that NMP22
BladderChek results are not hindered by the common occurrence of blood
in urine samples. Other urine tests often exhibit false-positives or
do not return an answer when blood contaminates the sample.
Matritech's microtiter plate format of the NMP22 test received FDA
approval in 1996. This laboratory test also measures the level of
NMP22 in urine.
Rapid Results
NMP22 BladderChek provides a patient with an immediate answer
about his or her status. With other cancer tests, the patient must
often go home and wait several days for lab test results. With NMP22
BladderChek, the patient receives an answer in the comfort of the
doctor's office where he or she can ask additional questions and
discuss next steps.
How NMP22 BladderChek Works
The technology identifies proteins that are highly overexpressed
in bladder cancer patients. Matritech and Massachusetts Institute of
Technology researchers discovered 10 years ago that high levels of the
nuclear matrix protein, NMP22, in urine frequently indicated the
presence of cancer. NMPs are found in the nuclei of cells where they
contribute to the nuclear structure and regulate various cell
functions. NMP22 is elevated in bladder cancer cells by 20 to 80 fold
and is released into the urine of bladder cancer patients.
NMP22 BladderChek contains two antibodies in the small testing
cassette; one antibody is in the area where the urine is introduced
into the device. Attached to this antibody are tiny gold particles. As
the urine flows over the antibody containing the gold, the NMP22
proteins are captured by them. This protein/antibody complex migrates
up to the reading window where the second antibody is located.
The complex attaches to this second antibody. If there are enough
NMP22 proteins collected at this point, light defracts from the gold
particles producing a purple line, indicating the patient is positive
for bladder cancer.
Matritech's Product Pipeline
FDA clearance for the NMP22 point-of-care test marks a significant
milestone for the company by providing further validation of
Matritech's proprietary technology. The BladderChek point-of-care
format could be applied to other cancers such as breast and prostate.
Matritech is currently conducting clinical trials for laboratory-based
tests for these cancer types.
About Matritech
Matritech is a leading developer of proteomics-based diagnostic
products for the early detection of cancer. Using its patented
proteomics technology, Matritech has identified proteins correlated
with breast, bladder, prostate, cervical and colon cancers. Matritech
is one of the first companies to successfully employ proteomics to
create diagnostic products. The Company holds one of only two FDA
tumor marker approvals for the initial detection of cancer. The
FDA-approved NMP22 bladder cancer test is currently used by
urologists. In addition, the Company has a promising blood-based
breast cancer test, NMP66, in clinical trials. Initial research on a
prostate cancer marker, NMP48, identified by Matritech scientists
shows the marker to be more accurate than the widely used PSA test.
NMP technology is licensed exclusively to Matritech from the
Massachusetts Institute of Technology.
Statement Under the Private Securities Litigation Reform Act
Any forward-looking statements related to the Company's
expectations regarding its current and future products, regulatory
approvals and expected customer sales 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, or denials of 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 assurance that the Company's
expectations for its products will be achieved.
--30--KC/bo
CONTACT: FH/GPC
Media Relations:
Heather McDonald, 617/646-1052
Cell: 617/797-3497
or
Matritech
Investor Relations:
John Doherty, 617/928-0820 ext. 224
KEYWORD: MASSACHUSETTS |
