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Visible Genetics Preparing TruGene HIV Genotyping Assay FDA Submission

This article was originally published in The Gray Sheet

Executive Summary

Visible Genetics, Inc. is looking to file an FDA application for its TruGene HIV genotyping assay kit in the first half of 2000, the company reported Nov. 30 at a BancBoston Robertson Stephens health care conference in New York City.

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Visible Genetics, Inc.

Private placement of 1.9 mil. shares with U.S. and European institutional investors raises $28.7 mil. A portion of the funds will be used to gear up U.S. marketing and manufacturing efforts for the TruGene HIV-I genotyping kit, an FDA regulatory submission for which is anticipated in the first half of 2000 (1"The Gray Sheet" Dec. 6, p. 14). The proceeds will be directed toward new product development and for general working capital, the Toronto firm says

Visible Genetics, Inc.

Private placement of 1.9 mil. shares with U.S. and European institutional investors raises $28.7 mil. A portion of the funds will be used to gear up U.S. marketing and manufacturing efforts for the TruGene HIV-I genotyping kit, an FDA regulatory submission for which is anticipated in the first half of 2000 (1"The Gray Sheet" Dec. 6, p. 14). The proceeds will be directed toward new product development and for general working capital, the Toronto firm says

HIV Genotyping Drug Resistance Assays Should Be Downclassified - Panel

Downclassification of HIV genotyping drug resistance assays with special controls would serve the public health interest and "be of use to every AIDS patient in the lifetime of their illness," FDA staffers asserted Sept. 17 before the Blood Products Advisory Committee.

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