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
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.