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

Cytyc

This article was originally published in The Gray Sheet

Executive Summary

Chlamydia and gonorrhea testing directly from Cytyc ThinPrep Pap Test collection vial samples using Roche's Cobas Amplicor automated test system gains PMA supplement approval. Cytyc had indicated it would reevaluate a related October 2000 co-marketing agreement with Roche following its February agreement to purchase HPV test maker Digene, which also has chlamydia and gonorrhea testing technology. Roche announced June 6 that it will develop an HPV test to compete with Digene's, in a market expected to exceed $600 mil. by 2010, after acquiring HPV patents from Institut Pasteur. Ironically, the prospect of increased competition could simultaneously make the Digene purchase less attractive to Cytyc and more likely to receive anti-trust clearance, which is pending. Cytyc extended its offer for a sixth time on June 7, to June 21, following submission of requested information to FTC May 28 (1"The Gray Sheet" June 3, 2002, In Brief)...

You may also be interested in...



US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.

Oncology Drug Safety Is Key Focus In US FDA’s Generic Label Updates

US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.

EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions

The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.

UsernamePublicRestriction

Register

MT016685

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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