translation agency

PR Newswire
Visible Genetics' Trugene HIV-1 Genotyping Test and Hardware

July 10, 2001
TORONTO, July 10 /PRNewswire/ -- Visible Genetics Inc. (Nasdaq: VGIN) (VGI) today announced that it has received licenses for its TRUGENE(TM) HIV-1 Genotyping Test and hardware from the Therapeutics Product Directorate (TPD) of Health Canada. In Canada, each individual component of the OpenGene system - the DNA sequencer and accessories, the MicroCels(TM), the Toaster(TM), the TRUGENE(TM) HIV-1 Genotyping Test and the software -- is filed and reviewed separately. VGI has received licenses for all components except for the software that generates the reports. Approval for the software is expected by the fourth quarter of this year. In the mean time, the hardware and kits can be freely sold for routine clinical or research use throughout Canada.

Health Canada estimates that there are approximately 50,000 individuals infected with the HIV virus in the country, of which about 14,000 are under active treatment. In Canada, HIV genotypic testing is usually performed in federal or provincial Public Health Laboratories. In January this year, Health Canada issued a notice to all hospital administrators, biomedical engineers and purchasing agents entitled, "Purchase of licensed medical devices for use in health care", reminding them that only licensed products can be sold in Canada. VGI now has the only licensed HIV genotyping product in Canada.

"We have been using the TRUGENE HIV genotyping product in our research lab as part of HIV drug trials and other projects. We have been very pleased with the performance of the product and the support we have received from Visible Genetics," said Dr. Brian Conway, MD, FRCPC, Assistant Professor in the Department of Pharmacology and Therapeutics at the University of British Columbia. "HIV genotyping is an important tool in the management of HIV infected patients. It is a significant development that there is now an approved HIV genotyping test for sale in Canada for routine use." Dr. Conway is an internationally recognized researcher in the HIV field whose main areas of interest include HIV clinical care, antiretroviral drug resistance testing, and NIH-funded work in the field of acute and early HIV infection.

Dr. Mark A. Wainberg, former president of the International AIDS Society and director of the McGill University AIDS Centre in Montreal, stated that "HIV genotyping is increasingly becoming an essential component of patient management to guide treatment in the aftermath of drug resistance. Visible Genetics' technology represents a highly effective means of determining mutations associated with HIV drug resistance". Dr. Wainberg works at the Jewish General Hospital and is a Professor in the Department of Microbiology and Immunology and in Medicine at McGill University, both in Montreal. His areas of specialty include antiretroviral drug resistance and antiretroviral drug development.

"Canada is the third country, after Argentina and France, that has approved our HIV genotyping test," stated Richard T. Daly, President and CEO of Visible Genetics. "This approval provides additional confirmation of the company's products and strategy in HIV genotyping. Our TRUGENE(TM) HIV-1 Genotyping Test and OpenGene(TM) System are also currently under review at the U.S. Food and Drug Administration (FDA)."

Visible Genetics Inc. is a leader in the emerging field of pharmacogenomics, which uses genetic information in the identification and analysis of genes to improve patient care and reduce healthcare costs. VGI manufactures and markets high performance automated DNA sequencing systems and complete kits for the analysis of genes linked to disease. The Company's OpenGene(TM) system employs patented CLIP technology -- a single-step, bi-directional sequencing method that significantly reduces the time and cost involved in identifying clinically relevant genetic information.

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks, uncertainties and other factors which may cause the Company's results to differ materially from expectations. These include risks relating to the ability to obtain regulatory approval, market acceptance of genotyping and the Company's products, delays in, or the refusal of, insurance companies and other third-party payors to reimburse us for our products, delays in product development, delays in making the new Atlanta manufacturing facility operational, and other risks as detailed from time to time in the Company's SEC filings, including its most recent Annual Report on Form 20-F. These forward-looking statements speak only as of the date hereof. VGI disclaims any intent or obligation to update these forward-looking statements.

SOURCE Visible Genetics Inc. Web Site: http://www.visgen.com



www.aegis.org