This article was originally published in The Gray Sheet
Test kit for detecting previously undiagnosed bladder cancer is scheduled for FDA panel review on Dec. 13, the company reports Oct. 26. The kit is currently cleared in the U.S. for monitoring the recurrence of bladder cancer, and is approved for use in screening in Japan. U.S. approval is anticipated in early 2000. Clinical study results submitted to FDA show the test to be 85% sensitive in detecting later stage, more life-threatening forms of bladder cancer in previously undiagnosed patients who presented a risk profile of smoking and blood in urine. The test kit was also more than twice as sensitive as urine cytology in identifying early-stage, low-grade bladder cancer. When used in conjunction with urine cytology, the test kit identified 100% of the late-stage invasive bladder cancers, whereas 45% of these conditions would have been missed using urine cytology alone
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