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meets the standards set forth in an August FDA Center for Biologics Evaluation and Research (CBER) special controls draft guidance for in vitro HIV drug resistance genotype assays.