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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. 2 FOR THE MONTH OF DECEMBER, 2000
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 / /
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 December 20, 2000, we announced that we have been granted French
regulatory approval for our TRUGENE(TM) HIV-1 Genotyping Kit by the Agence
Francaise De Securite Sanitaire Des Produits de Sante. Our TRUGENE HIV-1
Genotyping Kit is the first sequence based DNA test to be approved in the French
market.
French regulatory approval followed submission and review of relevant
information as required by the French regulatory authorities. Some of the
information contained in the submission was also contained in the file we
submitted for review to the U.S. Food and Drug Administration in September,
2000. Additional studies were required by the French regulatory authorities and
data generated in those studies demonstrated accuracy of 98.4% and
reproducibility of 99.7%. The French trial sites sequenced samples of both
subtype B and non B strains of HIV which are common in France.
We believe that we are currently able to launch the TRUGENE HIV-1
Genotyping Kit in the rest of the European Union (EU) member states. We
expect that further product approvals will not be required in the EU until
new EU wide regulations go into effect. We anticipate being in compliance
with the new regulations as they become effective.
Currently there are approximately 200,000 patients receiving HIV drug
treatment in Europe. With French regulatory approval, we anticipate launch of
the TRUGENE HIV-1 Genotyping Kit will be underway in Europe in the first
quarter of 2001. The TRUGENE HIV-1 Genotyping Kit is now positioned to become
a significant component of standard of care for HIV patients in Europe.
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 our 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: December 20, 2000 By: /s/ RICHARD T. DALY
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Name: Richard T. Daly
Title: President and Chief
Executive Officer
