Scrip 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


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.






Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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