Ventana Preparing HPV Test Submission, Will Co-Market With ChromaVision
This article was originally published in The Gray Sheet
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 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
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 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.