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