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

UsernamePublicRestriction
UsernamePublicRestriction

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

This article was originally published in The Gray Sheet

Executive Summary

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meets the standards set forth in an August FDA Center for Biologics Evaluation and Research (CBER) special controls draft guidance for in vitro HIV drug resistance genotype assays.

You may also be interested in...



Visible Genetics, Inc.

Genotyping kits for hepatitis B and C will be available for research use on VGI's OpenGene DNA sequencing system early in 2002, the firm predicts. The Toronto firm gained 510(k) clearance for its Trugene HIV-1 genotyping kit for use with the system on Sept. 26 (1"The Gray Sheet" Sept. 3, 2001, p. 10). The first HIV drug-resistance test available in the U.S., the test includes software to aid in antiretroviral drug selection. The hepatitis tests will tell physicians which variant of hepatitis B or C is afflicting the patient

Visible Genetics, Inc.

Genotyping kits for hepatitis B and C will be available for research use on VGI's OpenGene DNA sequencing system early in 2002, the firm predicts. The Toronto firm gained 510(k) clearance for its Trugene HIV-1 genotyping kit for use with the system on Sept. 26 (1"The Gray Sheet" Sept. 3, 2001, p. 10). The first HIV drug-resistance test available in the U.S., the test includes software to aid in antiretroviral drug selection. The hepatitis tests will tell physicians which variant of hepatitis B or C is afflicting the patient

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.

UsernamePublicRestriction

Register

LL1135544

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