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Biotech / Medical : Visible Genetics Inc.(VGIN)
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To: Piotr Koziol who started this subject9/29/2001 2:25:04 AM
From: Henrik   of 337
 
Visible Genetics HIV-1 Genotyping System Cleared by FDA

NEW YORK (Reuters Health) Sept 27 - Visible Genetics said on Wednesday that its Trugene HIV-1 Genotyping Kit and OpenGene DNA sequencing system have received final market clearance for clinical use from the US Food and Drug Administration.

The Trugene kit is used in conjunction with the company's OpenGene system. Visible Genetics anticipates that it will begin to ship the product in mid- to late November.

Richard Daly, president and CEO of Visible Genetics, noted during a Thursday conference call that "this is the first time the FDA has looked at, and cleared for sale, any product that is based on sequencing technology."

The Trugene HIV-1 technology will act as a springboard for upcoming Visible Genetics products that help tailor therapy to individual patients, Daly added. "The company's fundamental strategy is to provide a technology and a platform that uses sequencing in the treatment of specific illnesses," he said. "HIV is the first."

Visible Genetics expects a North American launch of hepatitis B and hepatitis C Trugene tests for research use in the first half of 2002. Trugene oncology tests should launch for research purposes in the second half of 2002, Daly said.

hiv.medscape.com
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