-----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, MbfesmGcXixX2NIF1+lEOsEQRCYSKnkxOnG4c8i31XPOI1rvoUm3MwqgwEVTH0at hFTeLpaDjVx1VRLC1l6qAQ== 0000912057-00-030179.txt : 20010524 0000912057-00-030179.hdr.sgml : 20010524 ACCESSION NUMBER: 0000912057-00-030179 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20000628 FILED AS OF DATE: 20000628 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: 663095 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 a6-k.txt 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. 1 FOR THE MONTH OF JUNE, 2000 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 X - - -------------------------------------------------------------------------------- VISIBLE GENETICS INC. On June 28, 2000 Visible Genetics Inc. issued a press release reporting on the status of its FDA submission for its TRUGENE HIV-1 Genotyping Kit. The press release is attached as Exhibit 1 to this Form 6-K and incorporated into this Form 6-K by reference. 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 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 and 333-94649) and our outstanding Registration Statements on Form S-8 and into the reoffer prospectuses contained therein. Exhibit -- Press Release dated June 28, 2000 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, 2000 By: /s/ RICHARD T. DALY --------------------------- Name: Richard T. Daly Title: President and CEO EX-99.1 2 ex-99_1.txt EXHIBIT 99.1 Exhibit 99.1 [LETTERHEAD OF VISIBLE GENETICS INC.] For Immediate Release Contacts: Richard Daly (416) 813-3281 Bruno Maruzzo (416) 813-3271 CEO, Visible Genetics Inc. Investor Relations, Visible Genetics Inc VISIBLE GENETICS REPORTS ON TRUGENE HIV-1 GENOTYPING KIT STATUS TORONTO, CANADA (June 28, 2000): Visible Genetics Inc. (VGI, Nasdaq: VGIN) reported today on the status of the US FDA submission for its TRUGENE HIV-1 Genotyping Kit. VGI has been working closely with the FDA to develop testing processes and trial parameters appropriate for the TRUGENE HIV-1 Genotyping Kit, which we believe would be the first ever sequencing-based diagnostic test submitted to the FDA for approval. In 1999, in consultation with the FDA, the Company began conducting a series of trials involving both human HIV plasma samples and laboratory-constructed molecular infectious clones (MICs). As of today, VGI has successfully completed and analyzed the results of the performance and analytic trials, including all trials involving human HIV plasma samples. The Company believes that the results of these tests confirm that the TRUGENE HIV-1 Genotyping Kit functions as intended and at the level of performance necessary to gain FDA clearance. VGI is currently performing one final study involving laboratory-constructed MICs rather than samples drawn from HIV infected patients. The Company has reviewed its progress to date with the FDA and expects to complete the one remaining study in the coming weeks and submit its application to the FDA in the third quarter of this year. The remaining study using the MIC panels does not require additional clinical trials or patient enrollment. "I am very pleased with the performance of our TRUGENE HIV-1 Genotyping Kit on the extensive set of clinical HIV samples studied in conjunction with preparing our FDA submission," said Richard T. Daly, President and CEO of VGI. "While the laboratory procedures associated with using MICs to construct experimental HIV samples have taken slightly longer than initially anticipated, we believe that the TRUGENE HIV-1 Genotyping Kit is on track to become the first sequencing-based diagnostic test to be allowed for marketing in the US." Visible Genetics Inc. is a leader in the emerging field of pharmacogenomics, which uses genetic information in the identification and analysis of genes to improve patient care and reduce healthcare costs. VGI 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 patented CLIP(TM) technology - a single-step, bi-directional sequencing method that significantly reduces the time and cost involved in identifying clinically relevant genetic information. This press release 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. VGI disclaims any intent or obligation to update these forward-looking statements. ### 2 -----END PRIVACY-ENHANCED MESSAGE-----