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Visible Genetics Trugene

This article was originally published in The Gray Sheet

Executive Summary

HIV-1 genotyping kit 510(k) submission to FDA is delayed by approximately three months as the firm conducts an additional study involving laboratory-constructed molecular infectious clones (MICs) rather than samples drawn from HIV infected patients, used in previous studies. The Toronto-based company previously had predicted a submission in the first half of 2000 (1"The Gray Sheet" March 6, p. 12). The study is scheduled for completion "in the coming weeks," and the submission will be made in the third quarter, making the kit "the first ever sequencing-based diagnostic test submitted to the FDA for approval," the company says
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