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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
FILING NO. 1 FOR THE MONTH OF SEPTEMBER, 2001
Visible Genetics Inc.
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(Exact name of Registrant)
700 Bay Street, Suite 1000, Toronto ON, Canada M5G 1Z6
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(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F
Form 20-F X Form 40-F
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Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
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VISIBLE GENETICS INC.
On September 26, 2001, we reported that we received clearance from the
U.S. Food and Drug Administration ("FDA") to market our TRUGENE(TM) HIV-1
Genotyping Kit and OpenGene(TM) DNA Sequencing System for routine clinical use,
becoming the first HIV drug resistance test to receive clearance from the FDA.
The TRUGENE HIV-1 Genotyping Kit and OpenGene System was submitted to
the FDA on September 5, 2000 as an "integrated system" comprised of the
chemistry, hardware, software and interpretive patient report necessary to
generate test results. The report provides information to the physician about
which antiretroviral drugs are likely to be effective in treating the HIV
infection of an individual patient.
The TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System is
intended for use in detecting HIV genomic mutations (in the protease and part of
the reverse transcriptase regions of HIV) that confer resistance to specific
types of anti-retroviral drugs, as an aid in monitoring and treating HIV
infection. It is intended for use as an aid to qualified clinicians in the
therapeutic management of HIV-1 infected patients in conjunction with all
relevant clinical and laboratory findings and the prescribing information of the
drugs in question.
This Form 6-K 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 our results to differ materially from
expectations. These include risks relating to the ability to obtain regulatory
approval, market acceptance of genotyping and our 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 detailed from time to time
in our SEC filings, including our most recent Annual Report on Form 20-F. These
forward-looking statements speak only as of the date hereof. We disclaim any
intent or obligation to update these forward-looking statements.
We hereby incorporate by reference this Form 6-K into our Registration
Statements on Form F-3, and into the prospectuses contained therein, (File Nos.
333-67607, 333-68939, 333-91155, 333-94649 and 333-40616) and our outstanding
Registration Statements on Form S-8 and into the reoffer prospectuses contained
therein.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
VISIBLE GENETICS INC.
Date: September 27, 2001 By: /s/ Marguerite Ethier
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Name: Marguerite Ethier
Title: Vice President and General Counsel