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HIV theranostic on track for 2000 submission:

This article was originally published in Clinica

Executive Summary

The US FDA has told Canadian pharmacogenomics company Visible Genetics that it need not complete the clinical trial of its Trugene HIV-1 genotyping kit for directing the treatment of HIV infected individuals. However, Toronto-based Visible Genetics will be required to finish its proficiency trial, which is designed to demonstrate Trugene's quality, reliability, accuracy and reproducibility. Data from the proficiency trial, which should be completed by the end of 1999, will be submitted to the FDA in the first half of 2000 as part of its market approval application for the kit.

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