Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - Wednesday December 20, 2000
French regulatory approval followed submission and review of relevant information as required by the French Regulatory Authorities. Some of the information contained in the submission was also contained in the file the Company submitted for review to the US Food and Drug Administration (FDA) in September 2000. Additional studies were required by the French regulatory authorities and data generated in those studies demonstrated accuracy of 98.4% and reproducibility of 99.7%. The French trial sites sequenced samples of both subtype B and non B strains of HIV which are common in France.
The Company is currently able to launch the TRUGENE HIV-1 Genotyping Kit in the rest of the European Union (EU) member states. Further product approvals will not be required in the EU until new EU wide regulations go into effect. The Company anticipates being in compliance with the new regulations as they become effective.
"We are very pleased to be the first company to have a sequence based test approved in France," stated Richard T. Daly, President and CEO of Visible Genetics. "For the past 18 months the company has built a strong European presence and infrastructure. Currently there are approximately 200,000 patients receiving HIV drug treatment in Europe, representing a significant market opportunity for Visible Genetics. With French regulatory approval, launch of the TRUGENE HIV-1 Genotyping Kit will be underway across Europe in the first quarter of 2001. The TRUGENE HIV-1 Genotyping Kit is now positioned to become a significant component of standard of care for HIV patients in Europe."
In an earlier press release, dated December 14, 2000, VGI reported it had received comments from the FDA on its US filing for the TRUGENE HIV-1 Genotyping Kit. The Company anticipates responding to FDA comments in January 2001. 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 of 1995. These forward-looking statements are subject to risks, 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, 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 as detailed from time to time in the Company's SEC filings, including the 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.
SOURCE: Visible Genetics Inc.
001220
PR001224
Copyright © 2000 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .