Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
PRNewswire - November 26, 2002
The GuideLines 6.0 Rules help to predict drug resistance in patients treated for HIV, by accessing a highly sophisticated algorithm developed and regularly updated by an international panel of leading HIV expert scientists and physicians. The GuideLines correlate the presence of different mutations in the HIV genetic code to the likelihood of the patient responding to treatment with different HIV drugs.
"GuideLines 6.0 provide physicians and patients with the latest information available on HIV resistance," said Dr. Richard D'Aquila, professor of medicine at the Vanderbilt University in Nashville, Tennessee. "Because HIV resistance is so complex and our knowledge is changing so quickly, it is critical that resistance testing is conducted using technology that is both fully validated and up-to-date."
Visible Genetics Inc. (VGI) of Toronto, which Bayer acquired October 11 of this year, developed the GuideLines software. The FDA granted its clearance under an expedited review process reserved for Special 510(k) submissions, allowing for more rapid introduction of the GuideLines.
GuideLines 6.0 Rules interpretation software system, part of the TRUGENE HIV-1 Genotyping Kit(1) and OpenGene(TM) DNA Sequencing System(1) now offered by Bayer, is able to predict how patients will respond to different HIV drugs with a high degree of accuracy. The interpretation of resistance information is critical in treatment and disease management decisions, and the ability to recognize mutations in the HIV genetic code is necessary to optimize therapy management.
"For physicians and patients, being able to test for resistance and interpret the complex results is vital to making treatment decisions. By providing the HIV-community with the latest data in HIV testing, we are fulfilling our commitment to give them the most up-to-date resistance information available anywhere in the world," said Peter Knueppel, senior vice president of Nucleic Acid Diagnostics, Bayer Diagnostics.
It is estimated that 900,000 Americans are infected with the human immunodeficiency virus (HIV). HIV is a virus that replicates rapidly; several billion new virus particles may be produced every day. Though the process is not fully understood, during this high level of replication random mutations can arise that can create variant strains resistant to certain drugs. Drugs that were once beneficial to a patient may become ineffective.
The GuideLines module interpretation software is updated regularly to incorporate newly discovered drug resistance mutations or add newly approved HIV drugs. The Version 6.0 update includes the latest information on newly launched drugs and will continue to address anticipated effects of pharmacologic boosting of protease inhibitor blood levels by co-administration of low-dose ritonavir, an important enhancement that was introduced with the Version 5.0 Rules. In keeping with FDA requirements, the 1212-page FDA submission included detailed documentation on the software development and validation process and a risk/hazard analysis of every proposed change in the software.
About Bayer Diagnostics
With approximately 7,000 employees worldwide and 2001 sales of $1.8 billion, Bayer Diagnostics (http://www.bayerdiag.com), based in Tarrytown, New York, USA, is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of central laboratory, self-testing, nucleic acid and near patient care diagnostics systems and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology, women's health and diabetes. Bayer Diagnostics is a part of the worldwide Bayer Group, a $29 billion international health care and chemicals group based in Leverkusen, Germany. Bayer Diagnostics' global headquarters in the United States operates as part of Bayer Corporation of Pittsburgh, a research-based company with major businesses in health care, life sciences and chemicals.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
(1) GuideLines Rules(TM) is cleared by the FDA as part of the TRUGENE(TM) HIV-1 Genotyping Kit and the OpenGene(TM) DNA Sequencing System. The TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System is intended for use in detecting HIV genomic mutations that confer resistance to specific types of anti-retroviral drugs, as an aid in monitoring and treating HIV infection. It is intended for use in conjunction with clinical presentation, prescribing information of the drug and other laboratory markers of HIV disease status as an aid in the therapeutic management of HIV-1 infected patients.
SOURCE Bayer Corporation
Web Site: http://www.bayerdiag.com
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PR021140
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