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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 DECEMBER, 1999
VISIBLE GENETICS INC.
(Exact name of Registrant)
700 BAY STREET, SUITE 1000, TORONTO ON, CANADA M5G 1Z6
(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 December 3, 1999, Visible Genetics Inc. (the "Company") announced
that the U.S. Food and Drug Administration (FDA) advised the Company
that it was not required to complete its clinical trial, SEARCH, for the
TRUGENE-TM- HIV-1 Genotyping Assay. The FDA does not require any further
demonstration of the clinical utility of HIV genotyping in the treatment of
HIV infected individuals. The Company will be required to complete its
Proficiency Trial, which is already underway. The results of the trial will
be part of the Company's market approval application to the FDA.
Based on the FDA's advice, the Company will continue to provide
genotyping to all patients currently enrolled in the SEARCH study. However,
enrollment of new patients into SEARCH has been closed.
The Company's multi-center Proficiency Trial, which should be
completed by the end of 1999, is designed to demonstrate the quality,
reliability, accuracy and repeatability of the TRUGENE-TM- HIV-1
Genotyping Assay and OpenGene-TM- DNA Sequencing System. Analysis
of the data from the trial, along with supporting documentation regarding the
manufacturing of the products, will be submitted to the FDA in the first half
of 2000, as part of the Company's market approval application.
Two prospective studies reported earlier this year, showed a
significant decrease in HIV viral load by using HIV genotyping to assist in HIV
drug selection. The VIRADAPT study, sponsored in Europe by the Company, and the
GART study, an independent study conducted in the U.S. 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 the control
arm. The VIRADAPT study was published in the June 26, 1999 issue of THE
LANCET, a peer-reviewed medical journal.
This Form 6-K 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. The Company disclaims any intent or obligation to
update these forward-looking statements.
The Company hereby incorporates by reference this Form 6-K into the
Company's Registration Statements on Form F-3 (File Nos. 333-67607, 333-68939
and 333-91155) and the Company's outstanding Registration Statements on Form
S-8 (File Nos. 333-6454 and 333-8804.).
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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 3, 1999 By: /s/ Richard T. Daly
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Name: Richard T. Daly
Title: President and C.E.O.
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