Matritech: Continuing Discussions With FDA >NMPS
(Copyright (c) 1998, Dow Jones & Company, Inc.)
NEW YORK (Dow Jones)--Shares of Matritech Inc. (NMPS) tumbled 29.7% on
heavy volume Wednesday morning after the company said the Food and Drug
Administration rejected the company's NuMA test kit for colon cancer.
As reported Tuesday, the FDA said the kit failed to meet 510k
marketing clearance criteria.
In a press release Wednesday, Matritech said the FDA's decision to
reject NumMA for for 510(k) marketing clearance "does not imply a
decision about the approvability of the product," adding the test is "on
track" for approval early in 1999.
The Newton, Mass., company said it applied for the 510(k) ruling to
speed up marketing clearance for NumMA. The 510(k) clearance is given
when a product is found to be substantially similar to another product
that has already received FDA clearance.
The NuMA test kit is a blood-based assay that uses Matritech's nuclear matrix protein technology for the management of colon-cancer patients.
The test kit detects a specific nuclear matrix protein, or NuMA, using
antibodies, to differentiate cancerous from normal specimens.
Matritech earlier hit a 52-week low of 2 1/2, passing the previous low
of 3 3/8 set Jan. 29. Recently, the shares were down 1 3/16 at 2 13/16,
on volume of 405,800 shares, compared with the daily average of 58,595. |
