In Brief: Digene
This article was originally published in The Gray Sheet
Executive SummaryDigene: Gains premarket approval application supplement approval to use its Hybrid Capture human papillomavirus (HPV) assay to test for HPV directly from Cytyc's PreservCyt sample vial -- which is currently used with the ThinPrep 2000 automated cervical sample preparation system. The approval allows a single cervical specimen preserved in PreservCyt solution to be microscopically evaluated via ThinPrep processing and then tested with the Hybrid Capture test if the screen is inconclusive. Digene entered a strategic alliance with Cytyc in October 1996 for joint marketing of Digene's Hybrid Capture HPV test and Cytyc's ThinPrep 2000 automated cervical sample preparation system ("The Gray Sheet" Oct. 14, I&W-7)...
You may also be interested in...
Companion diagnostics are needed increasingly by pharma companies to justify the safety and effectiveness of their products. With specific first-time EU regulation of these products within sight – and urgently needed – is there a risk of delays to these products being able to demonstrate compliance?
Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.
India’s Hilleman Laboratories says it’s aiming to develop an affordable vaccine that will target pregnant women in low- and middle-income countries to prevent Group B Streptococcus, a potentially fatal infection passed to babies during childbirth.