Digene gets FDA yes on HPV (Human Papilloma Virus) test, but with reservations
This article was originally published in Clinica
Executive Summary
An FDA advisory committee decision recommending that the agency approve the expanded use of Digene's DNA Pap test may not be as positive for the company as it seems, Clinica has learned. Early this month, the microbiology devices panel voted 6-2 on a motion that the company's Hybrid Capture 2 High-Risk HPV DNA test be approvable with conditions.
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