-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, F0zczfjQb6BYqc9mipfmA66hBRcNAmAd+WCqesPjF+IF0FIWYscUJ1xf3cZtmmP1 vl2xIwaE7DhfRn9H66aziw== 0001047469-98-045504.txt : 20010524 0001047469-98-045504.hdr.sgml : 20010524 ACCESSION NUMBER: 0001047469-98-045504 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19981224 FILED AS OF DATE: 19981230 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VISIBLE GENETICS INC CENTRAL INDEX KEY: 0001010819 STANDARD INDUSTRIAL CLASSIFICATION: 3826 IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: SEC FILE NUMBER: 000-28550 FILM NUMBER: 98778486 BUSINESS ADDRESS: STREET 1: 700 BAY ST STREET 2: SUITE 1000 CITY: TORONTO ONTARIO CANA STATE: A6 BUSINESS PHONE: 2127025700 MAIL ADDRESS: STREET 1: 700 BAY ST STE 1000 STREET 2: TORONTO ONTARIO CANADA CITY: M5G 1Z6 6-K 1 FORM 6-K - - -------------------------------------------------------------------------------- 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 --- --- - - -------------------------------------------------------------------------------- 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 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 EX-1 2 EXHIBIT 1 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. 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 -----END PRIVACY-ENHANCED MESSAGE-----