<PAGE>
- - --------------------------------------------------------------------------------
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, 1998
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
--- ---
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
--- ---
- - --------------------------------------------------------------------------------
<PAGE>
VISIBLE GENETICS INC.
The Company has received an allowance from the U.S. Food and Drug
Administration ("FDA") to initiate human clinical studies of the Company's
OpenGene(TM) HIV Genotyping system under the Company's Investigational Device
Exemption ("IDE") application. The successful execution of the clinical trials
is a necessary step in the process to obtain FDA approval to market and sell the
system in the United States for clinical use. The Company intends to commence
the first of its series of multi-site trials in early January 1999 in the United
States.
The OpenGene HIV Genotyping system that the Company will use in these
studies includes (among other components) the Company's MicroGene Clipper(TM),
GeneObjects(TM) Clinical Management System and the HIV TruGene(TM) Kit. This
system is designed to detect mutations in the genes of HIV in the blood of AIDS
patients. These mutations are known to cause the HIV virus to become resistant
to currently available drug therapies. The OpenGene HIV Genotyping system was
developed to enable physicians to identify the HIV mutation pattern in
individual patients and thereby optimize the selection of a successful drug
treatment. The system is currently being sold solely for research applications
in Europe and the United States.
The initial trial, called SEARCH I, will encompass approximately 20
U.S. physicians treating AIDS patients. The patients in the trial will be
divided into two groups: Group 1 will be retrospectively genotyped and the
results will not be available to the physicians, and Group 2 will be
prospectively genotyped and the physicians will be provided with the results.
Based on the drug resistance profile produced by the system for each Group 2
patient, the physicians will select a drug treatment program designed to best
depress the virus.
On or about December 24, 1998, the Company issued a press release with
respect to the foregoing.
The Company hereby incorporates by reference the text of this Form 6-K
(but not the Exhibit hereto) into the Company's Registration Statements on Form
F-3 (File No. 333-67607).
Exhibit 1. Press release - "Visible Genetics Inc. Receives FDA
Allowance For HIV Genotyping Trials."
2
<PAGE>
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 29, 1998 By: /s/ John K. Stevens
-------------------
Name: John K. Stevens
Title: Chairman of the Board, President and
Chief Executive Officer
3
<PAGE>
Visible Genetics Inc.
For Immediate Release
Contacts: Bruno Maruzzo (416)813-3271
David Sassoon (212)527-7453 Visable Genetics Inc.
Rowland-Wang Healthcare
Roanne Argyle (416)968-7311
Argyle Rowland Worldwide
Visible Genetics Inc. Receives FDA Allowance For HIV Genotyping Trials
- Significant milestone for VGI's genotyping products -
TORONTO, CANADA (December 24, 1998) Visible Genetics Inc. (NASDAQ: VGIN) today
announced that it has been allowed by the U.S. Food and Drug Administration
(FDA) to initiate human clinical studies of its OpenGene(TM) HIV Genotyping
system under its Investigational Device Exemption (IDE) application. As a result
of the FDA's decision, a multi-site series of validation and proficiency trials
for VGI's OpenGene HIV system will begin immediately. A pivotal, multi-site
clinical trial known as SEARCH I will begin early in January. This study will be
the keystone of the Pre-Market Approval (PMA) application. In addition, five
other U.S. trials using previously collected and banked specimens sponsored by
independent investigators will be supported by this IDE and VGI OpenGene
systems.
The VGI OpenGene system that will be used under the IDE include three major
components:
1. The MicroGene Clipper(TM): a clinical DNA sequencer designed for genotypic
applications. The sequencer has been optimized for rapid, accurate and
reproducible results combined with high sensitivity and minimal labor
requirement for genotypic applications. The sequencer can do a genotypic
analysis of the gag/pol region of HIV in less than 30 minutes, as compared
to research sequencers that may take from two to six hours.
2. The GeneObjects(TM) Clinical Management System: an integrated software
package that provides control of the Clipper, performs analysis of the
data, checks for contamination, and features full error detection and error
correction of the DNA sequence. The package is capable of going from raw
sequence data to a full resistance report in less than fifteen minutes.
3. The HIV TruGene(TM) Kit: an integrated chemistry kit that contains a
protocol, all reagents (approximately 20 components), and controls needed
to produce the material from the HIV in the AIDS patient's blood to final
sequence output on the Clipper. The kit makes use of CLIP, VGI's patented
method that provides full 3',5' sequence at reduced costs, and helps
optimizes error correction and detection.
<PAGE>
The VGI OpenGene system is designed to detect mutations in the genes of HIV in
the blood of AIDS patients. These mutations are known to cause the HIV virus to
be resistant to current drug therapy. By knowing the HIV mutation pattern in
each patient, a physician may optimize drug selection. OpenGene systems are now
in use for research applications in Europe and the US, and VGI has shipped
significant numbers of European HIV TruGene Kits this quarter.
"This is an important milestone for the Company and, is to our knowledge the
first IDE allowed by the FDA for any genotyping product," said John K. Stevens,
C.E.O. of Visible Genetics. "We have worked hard to meet the Current Good
Manufacturing Practice Standards (cGMP) requirements set by the FDA for our
kits, instruments and software. Genotyping, particularly HIV genotyping, is new
territory for everyone, and we have had positive and strong support from the FDA
in designing the necessary protocols and approaches to demonstrate clinical
utility of this new method as well as validation of our system. This IDE
allowance is the first important step to obtaining full PMA clearance in the
U.S. "
SEARCH I will be a US-based prospective trial that will use about 20 AIDS
physicians. Two groups of patients will be enrolled: Group 1 will be
retrospectively genotyped, and the results will not be available to the
physician, while Group 2 will be prospectively genotyped and the results will be
used by the physician to actually select drugs in an effort to maximally depress
the virus based on the HIV drug resistance profile produced by the OpenGene
System.
The SEARCH I design is similar to the VGI sponsored French VIRADAPT study,
presented Nov 12th 1998 at the 4th International Congress on Drug Therapy in HIV
Infection in Glasgow. The VIRADAPT results showed statistically significant
reduction of about 0.5 log units in viral levels in the genotypic arm at both
three month and six month analysis points. In addition, preliminary economic
analysis of the VIRADAPT data showed that each dollar spent on genotyping saved
approximately $3.83 in non-drug based costs.
Visible Genetics Inc. manufactures and markets high performance automated DNA
sequencing systems and complete kits for the analysis of genes linked to
disease. The Company's OpenGene(TM) system employs proprietary stratified DNA
testing and single-tube, single-step sequencing methods to significantly reduce
the time and cost involved in identifying clinically relevant genetic
information. VGI is a leader in the emerging field of pharmacogenomics, which
will use genetic information in the identification, and analysis of genes in
order to improve patient care and reduce healthcare costs.
###
2
