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Biotech / Medical : Visible Genetics Inc.(VGIN) -- Ignore unavailable to you. Want to Upgrade?

To: Kelton who wrote (309)	9/20/1999 9:39:00 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 337

serious good news, but..... I'm confused...... doesn't 510(k) usually imply that there's already an approved assay for the given application?....... Monday September 20, 6:59 am Eastern Time Company Press Release SOURCE: Visible Genetics Inc. FDA Advisory Committee Recommends Reclassification of HIV Genotyping Drug Resistance Assays to Class II with Special Controls -- Reclassification Could Pave the Way for More Targeted HIV Treatments -- TORONTO, Sept. 20 /PRNewswire/ -- Visible Genetics Inc. (VGI) (Nasdaq: VGIN - news) reported today that on Friday the U.S. Food and Drug Administration's (FDA) Blood Products Advisory Committee (BPAC) recommended the reclassification of all HIV genotyping drug resistance assays from Class III to Class II with special controls. BPAC's recommendation will affect Visible Genetics' TruGene(TM) HIV-1 Genotyping Assay. The committee voted to reclassify these assays based on several factors, such as the availability of sufficient clinical data about the utility of the assays; adequate scientific and clinical data supporting safety; and the FDA's own recommendation. The special controls suggested were testing guidelines, performance standards and post-marketing surveillance. The Class II designation, which requires a Pre-Market Notification (also known as a 510(k)) to get market approval, requires scientific data to be presented that demonstrates the safety and reliability of the device for its intended use, and demonstrates that any risk can be mitigated by special controls. A Class III designation carries a Pre-Market Approval (PMA) route-to-market and is used for products considered to pose greater risk to the public. 510(k) applications are generally less detailed than PMAs with fewer clinical studies required to demonstrate effectiveness and clinical utility and are generally reviewed and approved more rapidly than manufacturers' PMA applications. 510(k) applications have a 90-day review cycle, while PMA applications have a review cycle of 180 days. ''This action clearly demonstrates that the Committee understands the dramatic impact genotyping assays can have in helping physicians more accurately identify therapies that will address resistance in individual patients with the HIV virus,'' said Dean Winslow, MD, VGI's vice-president of Regulatory and Clinical Affairs. ''VGI will continue working closely with the FDA to ensure that this important technology is approved and available to physicians and patients in the most timely fashion.'' According to a recent study published in the Journal of the American Medical Association, more than 230,000 people in the United States sought treatment for HIV/AIDS in 1996 (1). HIV's ability to mutate in the wake of these treatments is causing once-successful drugs to fail and puts AIDS patients in a perilous position. With approximately 40,000 new cases of HIV occurring in the United States every year (2), emerging mutations pose a significant health threat. ''In the face of drug resistance and multiple drug therapies, choosing a standardized, reproducible assay will be a critical element in the future of HIV treatment,'' said R. Scott Hitt, MD, chairman of the President's Advisory Council on HIV/AIDS. ''This much needed technology is necessary for choosing appropriate anti-retroviral therapy for people living with HIV/AIDS.'' The President's Advisory Council, made up of HIV experts from all over the country, works directly with the Office of National AIDS Policy to recommend Federal policies in response to the HIV epidemic. ''Based upon published data, HIV drug resistance testing can help improve the selection of a treatment regimen,'' said Jules Levin, Executive Director of the National AIDS Treatment Advocacy Project (NATAP). ''It should be used along with other information such as treatment history. Although the tests have strengths and weaknesses and need further refinement, they can help to identify drugs that a person may have resistance to and drugs to which a person may not have resistance. It is imperative for public and private insurers to provide reimbursement for this technology.'' In December 1998, Visible Genetics was granted an Investigational Device Exemption (IDE) for the TruGene(TM) HIV-1 Genotyping Assay which allows VGI to conduct clinical trials. Under its IDE, VGI will launch next month a 200-patient pilot study as part of the Vigilance II study, the first large-scale trial in North America to develop a prevalence database of HIV drug resistance and to assess clinical outcomes using this new technology. The study, an open-label, cost-recovery HIV genotyping study, will enroll up to 30,000 U.S. patients and use the TruGene(TM) HIV-1 Genotyping Assay. In addition, in June 1999, VGI launched a prospective multi-center, controlled clinical trial of genotyping-assisted anti-retroviral therapy. The U.S.-based study, known as SEARCH, uses the TruGene(TM) HIV-1 Genotyping Assay results for actual treatment selection. The SEARCH design is similar to the VGI sponsored French VIRADAPT study that showed a significant reduction in viral load in the group where genotype results were used to guide treatment decisions (3). 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 to improve patient care and reduce healthcare costs. For more information on VGI visit visgen.com. 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. (1) Shapiro, MF, et al. Variations in the care of HIV-infected adults in the United States. ''Journal of the American Medical Association.'' 1999; 281:2305-2315. (2) Trends in HIV & AIDS. 1998. Centers for Disease Control and Prevention. (3) Durant, J. et al. Drug-resistance genotyping in HIV-1 therapy; the VIRADAPT randomized controlled trial. ''Lancet.'' 1999; 353: 2195-99. SOURCE: Visible Genetics Inc.