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.