REDMOND, Wash--The FDA has given premarket approval to a new tumor antigen test for detecting bladder cancer recurrence, and an FDA advisory panel has recommended approval of a second bladder cancer assay that measures nuclear matrix proteins.
Now available from Bard Diagnostic Sciences, the diagnostic subsidiary of C.R. Bard Inc, is the Bard BTA (bladder tumor antigen) test.
A multicenter clinical trial of nearly 500 bladder cancer patients undergoing surveillance cystoscopy for recurrence showed that the new test is at least as sensitive as, and in many cases better than, voided urinary cytology.
Among patients with low-stage, low-grade tumors, the BTA test detection rate was nine times greater than that of cytology, said Michael Sarosdy, MD, professor and Chief of Urology, University of Texas Health Science Center, San Antonio, and the lead author of the study report (J Urol 154:379-384, 1995).
Test Measures NMP22
Matritech Inc.'s bladder cancer assay, the NMP22 Test Kit, has been recommended as "approvable with condition" by the FDA's Immunology Devices Panel. The company must provide data on an additional number of certain subjects, but another panel hearing will not be necessary.
The new test measures urinary levels of NMP22, a nuclear matrix protein that has been found to be elevated in the urine of patients with bladder cancer. Studies show that the new test is twice as sensitive as urine cytology for detection of transitional cell carcinoma of the urinary tract, which accounts for more than 90% of bladder cancers, the company said.