Medtech Insight 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


In Brief: Digene

This article was originally published in The Gray Sheet

Executive Summary

Digene: Submits premarket approval application supplement to FDA for its Hybrid Capture II human papillomavirus DNA test. The test is a next generation to the firm's Hybrid Capture test, permitting "simultaneous testing of multiple samples from a single 96-well microtiter plate." When used in conjunction with Pap smear testing, the Hybrid Capture II test can detect 95-100% of high grade lesions and "virtually all instances of cervical cancer," Digene claims. The Beltsville, Maryland firm plans to develop the test's format to allow simultaneous testing of HPV, chlamydia and gonorrhea from a single patient specimen, and it expects to submit 510(k)s to FDA for tests for those diseases in 1998...



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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