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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 May, 1999
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 May 19, 1999, Visible Genetics Inc. (the "Company") announced that,
following FDA protocol review, it will proceed under its December 1998
Investigational Device Exemption (IDE) with Vigilance II, a US based open label,
cost recovery HIV Genotyping study.
Vigilance II will use the Company's TruGene(TM) HIV-1 Assay kit,
OpenGene(TM) DNA sequencing system, and GeneObjects(TM) software. The Company's
tests and kits will be reimbursable through third party, private and public
payors on a cost recovery basis. The study has an enrollment target of 30,000
patients. The Company expects active patient enrollment to begin in the next
three to four months. The Company also intends to use the data in the study to
create a large-scale research database of HIV resistance profiles with clinical
outcomes which will be made available to scientists, physicians and others via
the Internet.
Dr. Thomas C. Merigan, a director-nominee of the Company, and Becker
Professor of Medicine and Director Center for AIDS Research, Stanford
University, will serve as the principal investigator for the study.
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 and uncertainties
including delays in the start of the study, lower than expected patient
enrollment and other risks detailed from time to time in the Company's SEC
filings, including its prospectuses dated December 3, 1998 and January 4, 1999.
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 and
333-68939).
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: May 19, 1999 By: /s/ Jeffrey D. Sherman
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Name: Jeffrey D. Sherman
Title: Vice President, Finance and
C.F.O.