In Brief: Matritech
This article was originally published in The Gray Sheet
Executive Summary
Matritech: Premarket approval application for the firm's NMP22 bladder cancer test will be reviewed by FDA's Immunology Devices Advisory Panel at its Nov. 30 meeting, Matritech announces Oct. 31. The test is designed to detect cancer cells' nuclear matrix proteins. Matritech submitted the PMA in November 1994 ("The Gray Sheet" June 19, p. 32). The firm also says it has terminated its co-marketing agreement with Hybritech for the NMP22 in the wake of Hybritech's acquisition by Beckman Instruments ("The Gray Sheet" Oct. 2, p. 3). Matritech plans to develop its own direct sales force for the microtiter plate kits and is in discussion with potential partners for marketing an automated version of the test...