Matritech's NMP22
This article was originally published in The Gray Sheet
Executive Summary
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
You may also be interested in...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.