Industry News (Screening)

Bladder Cancer Test Scheduled for Review by Immunology Devices Panel

Published in Cancer Weekly, November 13th, 1995

Matritech, Inc., Cambridge, Massachusetts, announced that the company's Pre-Market Application (PMA) seeking U.S. Food and Drug Administration (FDA) approval of the Matritech NMP22 Test Kit for bladder cancer is scheduled for formal review on November 30, 1995, by the Immunology Devices Panel of the Medical Devices Advisory Committee to the FDA.

NMP22 is the first nuclear matrix protein-based immunodiagnostic product to be reviewed by the FDA for sale in the United States. Matritech will present its clinical trial data, which the panel will consider. The panel typically makes a non-binding recommendation to the FDA concerning any issues or questions presented to the...

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Source: Cancer Weekly (1995-11-13)

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