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

Ventana Preparing HPV Test Submission, Will Co-Market With ChromaVision

This article was originally published in The Gray Sheet

Executive Summary

Ventana Medical Systems plans to seek premarket approval for its Inform human papilloma virus (HPV) test by year-end as a follow-up screen for women whose Pap results show atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intra-epithelial lesions (LSIL)

You may also be interested in...



Digene Still Expecting HPV DNA Pap Test Primary Screen Approval By 2003

Digene will re-analyze pivotal study data to demonstrate clinical utility of its HPV DNA Pap test as a primary screen for cervical cancer in response to an FDA request for additional information

Real World Data Failed To Impress Kaftrio’s European Reviewers

The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.

Swissmedic Clears Up Confusion Over Validity Of GMP Certificates

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.

UsernamePublicRestriction

Register

OM004967

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