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