Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

HIV Genotyping Drug Resistance Assays Should Be Downclassified - Panel

This article was originally published in The Gray Sheet

Executive Summary

Downclassification of HIV genotyping drug resistance assays with special controls would serve the public health interest and "be of use to every AIDS patient in the lifetime of their illness," FDA staffers asserted Sept. 17 before the Blood Products Advisory Committee.

You may also be interested in...



VGI Awaiting 510(k) Clearance For Trugene; FDA Drafts Guidance Document

Visible Genetics, Inc.(VGI) is confident that the clinical data for the company's Trugene HIV-1 genotyping test meets the standards set forth in an August FDA Center for Biologics Evaluation and Research (CBER) special controls draft guidance for in vitro HIV drug resistance genotype assays.

VGI Awaiting 510(k) Clearance For Trugene; FDA Drafts Guidance Document

Visible Genetics, Inc.(VGI) is confident that the clinical data for the company's Trugene HIV-1 genotyping test meets the standards set forth in an August FDA Center for Biologics Evaluation and Research (CBER) special controls draft guidance for in vitro HIV drug resistance genotype assays.

VGI Trugene HIV-1 Test Downclassification Petition Anticipated By August

Visible Genetics, Inc. plans to submit a petition to FDA by August seeking classification of its Trugene HIV-1 genotyping test and OpenGene DNA sequencing system as Class II following FDA's rejection of a September 2000 510(k) submission.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT012350

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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