Tuesday September 5, 7:05 am Eastern Time
Press Release
SOURCE: Visible Genetics Inc.
Visible Genetics Submits TRUGENE(TM) HIV-1
Genotyping Kit Application to The FDA
- Application Submitted for Industry First Pharmacogenomic Drug Resistance
Testing -
TORONTO, Sept. 5 /CNW/ -- Visible Genetics Inc. (Nasdaq: VGIN - news; VGI) is pleased to announce that it has
delivered its submission to the FDA for its TRUGENE(TM) HIV-1 Genotyping Kit and OpenGene(TM) DNA sequencing
system. The FDA submission details the results of an extensive series of tests performed using the TRUGENE(TM) kit. The
tests, conducted on a wide range of clinical plasma samples as well as molecular infectious clones, demonstrated that the
Company's system is capable of rapidly and consistently delivering accurate results in the clinical setting.
"The company has reached a major milestone," stated Richard T. Daly, president and CEO of Visible Genetics. "VGI is leading
the way in achieving the promise of pharmacogenomics and the personalization of medicine based on genetic variations. We are
pleased to have submitted to the FDA what the company believes is the first DNA sequence-based product intended for
clinical application. We believe the TRUGENE(TM) kit and OpenGene(TM) DNA sequencing system represent the beginning
of a new era of clinical care using DNA sequencing technology."
The TRUGENE(TM) kit is used with VGI's proprietary integrated OpenGene(TM) DNA sequencing system to identify genetic
mutations in the HIV virus. The information is valuable because specific mutations in the individual patient make the virus
resistant to some drugs. By using viral resistance information from the patient, physicians can better prescribe appropriate drug
regimens thereby improving individual patient care. A number of randomized clinical trials including GART, VIRADAPT and
NARVAL, have demonstrated improved patient care through use of HIV drug resistance testing using genotyping. If approved,
the TRUGENE(TM) HIV-1 Genotyping Kit will become the only FDA approved HIV drug resistance test on the market.
Visible Genetics, as well as other researchers using VGI's TRUGENE(TM) kits, will be presenting papers at the upcoming
Interscience Conference on Antimicrobial Agents and Chemotherapay (ICAAC) being held in Toronto from September 17th
to the 20th, confirming the benefits of HIV genotyping in the treatment of HIV/AIDS patients. Visible Genetics will have a
significant presence at the conference, including a demonstration of its products in the exhibit area. ICAAC is one of the
premier international conferences on infectious diseases and will provide an excellent venue for Visible Genetics to educate
physicians as to the importance of the TRUGENE(TM) HIV-1 Genotyping Kit.
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(TM) 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.
For further information
Richard Daly, CEO, 416-813-3281, or Bruno Maruzzo, Investor Relations, 416-813-3271, both of Visible
Genetics Inc.
Web site: visgen.com |
