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Matritech NuMA(TM) Test Kit FDA 510(k) Decision Has No Affect on Product
Approvability; Development On-Track
(Copyright (c) 1998, PR Newswire)
NEWTON, Mass., May 20 /PRNewswire/ -- Matritech, Inc. (Nasdaq: NMPS)
announced additional information on the determination from the U.S. Food and
Drug Administration (FDA) that its NuMA(TM) Test Kit for detecting colon
cancer does not meet the criteria for 510(k) marketing clearance.
"The FDA determination does not imply a decision about the approvability of
the product," said David L. Corbet, President of Matritech. "We continue to
be on-track with the Company's planned premarket approval application (PMA)
filing for the NuMA(TM) Test Kit product in early 1999."
"The 510(k) application strategy was an opportunistic approach to expedited
marketing clearance. Matritech is one of the first companies to try to use
newly effective tumor marker regulations to prove equivalence between two
completely different markers," Corbet continued. "The recent FDA decision was
based on our tests 'equivalence' to another test in a legal sense. This decision has nothing to do with ultimate approvability of the product. It has
also not delayed the PMA process in any way. This is a new and complex area
of interpretation, and we plan to continue discussions with our contacts at
the FDA on this topic."
"From the beginning of the regulatory process for NuMA, we have been
pursuing a dual-track regulatory strategy, which includes both a PMA filing
and a 510(k) filing, to ensure that we are able to expedite the approval of
the product," stated Mr. Corbet. "We have been pursuing a PMA filing as our
principal strategy, with the end goal being marketing clearance for screening
as well as the patient management indication."
The NuMA(TM) test kit is a blood-based assay that utilizes the Company's
nuclear matrix protein (NMP) technology for the management of colon cancer
patients. The test kit detects a specific NMP, NuMA, using proprietary
antibodies, to differentiate cancerous from normal specimens. Matritech has
retained worldwide manufacturing and marketing rights for NuMA. The NMP(R)22
Test Kit, approved by the FDA for sale in the United States in 1996, also uses
the NuMA protein.
Matritech, Inc., based in Newton, MA, is using its proprietary NMP technology, discovered at the Massachusetts Institute of Technology and
licensed exclusively to Matritech, to develop and commercialize innovative
serum-, cell-, and urine-based diagnostics that enable physicians to reliably
detect and monitor the presence of bladder, breast, cervical, colorectal and
prostate cancers. The Company's first product, the NMP-22 Test Kit for
bladder cancer, is on the market. All of Matritech's diagnostic assays are
based on the discovery that nuclear matrix proteins in cancer cells differ
from those in normal cells.
Any forward-looking statements related to the Company's expectations
regarding clinical trials and regulatory approvals 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
specimen collection, conduct of trials, analysis of data, preparation of FDA
submission and review and approval by the FDA and by other regulatory
authorities. There can be no assurance that the Company's current and future
products will obtain necessary regulatory approvals in a time period
consistent with the Company's past experience, or at all.
/CONTACT: Stephen D. Chubb, CEO, or David L. Corbet, President of Matritech, Inc., 617-928-0820 or Derek Caldwell of Sunrise Financial
Group, 212-421-1616/
09:04 EDT
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