This is another reason why PNP is moving....VGIN up $11 on the day today
NEW DHHS GUIDELINES CONFIRM ROLE OF HIV GENOTYPING GUIDELINES REFERENCE GART AND VIRADAPT STUDIES IN SUPPORTING CLINICAL UTILITY OF Genotypic Drug Resistance Testing
NEW DHHS GUIDELINES CONFIRM ROLE OF HIV GENOTYPING GUIDELINES
REFERENCE GART AND VIRADAPT STUDIES IN SUPPORTING CLINICAL UTILITY OF
Genotypic Drug Resistance Testing
TORONTO, Feb 7, 2000 /PRNewswire via COMTEX/ -- Visible Genetics Inc.
(VGI) (Nasdaq: VGIN) announced that the recently released U.S.
Department of Health and Human Services' (DHHS) "Guidelines for the Use
of Antiretroviral Agents in HIV- Infected Adults and Adolescents,"
further validates the potential utility of genotypic testing in the
clinical management of HIV drug therapy. The guidelines were developed
by the Panel on Clinical Practices for the Treatment of HIV Infection
convened by DHHS and the Henry J. Kaiser Family Foundation.
"The guidelines support the use of genotyping resistance tests as a
rapid means to assist in the selection of the appropriate antiviral
drug regimen in the treatment of HIV infected patients, especially in
cases of virologic failure," said Richard Daly, CEO of Visible
Genetics. "We are particularly encouraged that the prospective studies,
VIRADAPT and GART, were cited in the guidelines as indicating that the
short-term virologic response to therapy was significantly greater when
results of resistance testing were available."
The two prospective studies, reported last year, showed a statistically
significant decrease in HIV viral load by using HIV genotyping to
assist in HIV drug selection. The VIRADAPT study, sponsored in Europe
by VGI, and the GART study, an independent study conducted in the US by
the Community Program for Clinical Research on AIDS (CPCRA), both
showed a 0.5 log greater decrease in viral load for patients in the
genotyping arm of the study, versus those in the control arm. The
VIRADAPT study was published in the June 26, 1999 issue of The Lancet,
a peer-reviewed medical journal.
Further support for genotyping technology came last September when the
US Food and Drug Administration (FDA) Blood Products Advisory Committee
(BPAC) recommended the reclassification of all HIV genotyping drug
resistance assays from Class III to Class II with special controls.
Approval by the FDA of an HIV genotyping test will also address a key
concern cited in the DHHS guidelines that existing unapproved assays
"lack uniform quality assurance." VGI expects to file its FDA
submission in the first half of 2000.
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 1995. These forward-looking statements are
subject to risks and 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, and other
risks as detailed from time to time in the Company's SEC filings and
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.
(C) 2000 PR Newswire. All rights reserved.
prnewswire.com
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CONTACT: Paula Evangelista, Director of Public Relations, 215-491-0162,
or paula@visgen.com, or Bruno Maruzzo, Director of Investor Relations,
416-813-3271, or bruno@visgen.com, both of Visible Genetics Inc.
WEB PAGE: visgen.com
GEOGRAPHY: Ontario
INDUSTRY CODE: BIO
MTC
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