Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Matritech NMP22 Assay Approvable As Adjunct Bladder Cancer Diagnostic

This article was originally published in The Gray Sheet

Executive Summary

Labeling for Matritech's NMP22 urine assay should state that the product is for use "in conjunction with and not in lieu of" standard bladder cancer detection procedures, FDA's Immunology Devices Panel concluded Dec. 13.

You may also be interested in...



Matritech's NMP22

Firm anticipates early 2000 launch of the bladder cancer diagnostic kit for use as an aid in diagnosing transitional cell carcinoma in previously undiagnosed patients presenting with symptoms or other risk factors, following FDA sign-off on a premarket approval application supplement, announced Jan. 24. Approved in 1996 for monitoring for recurrence in previously diagnosed bladder cancer patients, the urine-based assay can now be marketed for use "in conjunction with, and not in lieu of, current standard diagnostic procedures," including cytology and cystoscopy, according to approved labeling. FDA's Immunology Devices Panel recommended that the agency approve the expanded indication with a diagnostic cut-off level of 7.5 units/mL at a Dec. 14 meeting (1"The Gray Sheet" Dec. 20, p. 4). Matritech says it is seeking a marketing partner to help distribute the test in the estimated $300 mil. worldwide market

Dr Reddy's Strengthens Russian OTC Portfolio Through Glenmark Deal

Dr Reddy's is poised to expand its OTC offering in Russia and certain CIS countries by snapping up a basket of allergy brands from India's Glenmark.

UsernamePublicRestriction

Register

OM006145

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel