Medtech Insight is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

FDA questions accuracy of OraSure's at-home HIV test ahead of panel meeting

This article was originally published in Clinica

Executive Summary

OraSure Technologies' OraQuick In-Home HIV test is set for a tough FDA panel review, after the agency found that some users get the wrong result. The Blood Products Advisory Committee is due to meet on 15 May to discuss whether the benefits of the diagnostic outweigh its risks; the agency usually follows the recommendations of its panels when deciding whether to approve products, but is not bound by them.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT098902

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

Cancel