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

Emergency approval for IntelligentMDx's H1N1 test

This article was originally published in Clinica

Executive Summary

An H1N1 test from IntelligentMDx (IMDx) has become the latest to be granted emergency use authorisation (EUA) from the US FDA for pandemic flu. The company claims the Influenza A H1N1 real-time RT-PCR assay is the first authorised for use on multiple instruments. This includes Applied Biosystems' 7500 Fast real-time PCR system and 7500 Fast Dx real-time PCR instrument. The test produces results in 90 minutes, Cambridge, Massachusetts-based IMDx says, and is intended for use in labs with high-complexity CLIA certification. The diagnostic will now be available for the duration of the emergency declaration, which is set to expire on April 26 2010.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT077104

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