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Visible Genetics, Inc.

This article was originally published in The Gray Sheet

Executive Summary

Maker and marketer of automated DNA sequencing systems plans to file in the third quarter a 510(k) with FDA for market clearance of its Trugene HIV-1 genotyping assay. In December, FDA had said the firm did not need to complete a clinical trial for inclusion in a premarket approval application, but that proficiency trials should be completed. Separately, second quarter financial results announced Aug. 17 included sales of $3.4 mil. (up 78.9%). A net loss of $8.6 mil. compares to a net loss of $7.1 mil. for the same quarter last year
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