Matritech NMP22 Assay Approvable As Adjunct Bladder Cancer Diagnostic
This article was originally published in The Gray Sheet
Labeling for Matritech's NMP22 urine assay should state that the product is for use "in conjunction with and not in lieu of" standard bladder cancer detection procedures, FDA's Immunology Devices Panel concluded Dec. 13.
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Firm anticipates early 2000 launch of the bladder cancer diagnostic kit for use as an aid in diagnosing transitional cell carcinoma in previously undiagnosed patients presenting with symptoms or other risk factors, following FDA sign-off on a premarket approval application supplement, announced Jan. 24. Approved in 1996 for monitoring for recurrence in previously diagnosed bladder cancer patients, the urine-based assay can now be marketed for use "in conjunction with, and not in lieu of, current standard diagnostic procedures," including cytology and cystoscopy, according to approved labeling. FDA's Immunology Devices Panel recommended that the agency approve the expanded indication with a diagnostic cut-off level of 7.5 units/mL at a Dec. 14 meeting (1"The Gray Sheet" Dec. 20, p. 4). Matritech says it is seeking a marketing partner to help distribute the test in the estimated $300 mil. worldwide market
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