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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 JUNE, 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 June 28, 2001, we announced that the US Food and Drug Administration
(the "FDA") has completed its review of our 510(k) submission for our
TRUGENE(TM) HIV-1 Genotyping Test and OpenGene(TM) system. The FDA has found our
product to meet its requirements for clearance, subject to ordinary course
labeling and other routine issues which will be addressed during the `DE NOVO'
process or after clearance.
As previously reported, after discussions with the FDA, we are pursuing
our FDA approval under accelerated procedures permitted under the Food and Drug
Administration Modernization Act of 1997. These procedures were designed to
enable applicants to shorten the FDA review process for certain types of
products.
Under these procedures, we submitted a 510(k) premarket notification to
the FDA, even though our TRUGENE(TM) HIV-1 Genotyping Test and OpenGene(TM)
system do not presently qualify as Class II devices because they are not similar
to existing devices already on the market. Therefore, as expected, the FDA has
now issued a `Not Substantially Equivalent' ("NSE") letter stating that,
although our products meet the FDA's requirements for safety and effectiveness,
since there is currently no similar legally marketed product in this category,
our product cannot be cleared as a 510(k) device. However, as contemplated under
the `DE NOVO" review process of the Modernization Act procedures, we will now
file a petition asking the FDA to classify the product as a Class II device
based on its safety compared to other products. We will file our petition within
30 days, and the FDA will then have 60 days to rule on the petition. During this
time and before final clearance can be granted, we will work with the FDA to
finalize any outstanding label issues. If the FDA grants the petition, it will
issue its order to permit us to begin commercial marketing based on its already
completed review of our 510(k) application.
This process of filing a 510(k) submission, receiving an NSE letter and
filing a petition under the Modernization Act, although circuitous, has resulted
in a shorter review process than if we had undertaken a premarket approval
approach.
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.
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: June 28, 2001 By: /s/ Richard T. Daly
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Name: Richard T. Daly
Title: President and Chief Executive Officer