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

Visible Genetics, Inc.

This article was originally published in The Gray Sheet

Executive Summary

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

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meets the standards set forth in an August FDA Center for Biologics Evaluation and Research (CBER) special controls draft guidance for in vitro HIV drug resistance genotype assays.

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

World-First Nod For Yuhan's Lung Cancer Drug, In Korea

The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.

UsernamePublicRestriction

Register

PS012935

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