Anthrax test, developed by army and CDC, receives FDA approvalAugust 31, 2005A method for identifying Bacillus anthracis, the causative agent of anthrax, has been cleared for diagnostic use by the U.S. Food and Drug Administration (FDA). The test, known as the Gamma Phage Assay, was modified by scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to improve its performance and reliability when used with clinical specimens. The original form of the Gamma Phage Assay was first developed by the Centers for Disease Control and Prevention (CDC) in the mid-1950s. The modified gamma phage method is the first diagnostic test to gain FDA approval for human use within the Laboratory Response Network (LRN). This network, established by the CDC, is charged with maintaining an integrated system of state and local public health, federal, military, and international laboratories that can respond to bioterrorism, chemical terrorism and other public health emergencies. According to USAMRIID senior scientist John W. Ezzell, the Gamma Phage Assay is a classical bacteriological method that has been used at USAMRIID and other laboratories for years as part of an extensive array of methods used to identify B. anthracis. The gamma phage is a virus capable of entering bacterial cells and causing cell destruction, or lysis-and it is specific to B. anthracis. "Because of that specificity, the gamma phage gives a highly readable result," Ezzell explained. "Wherever the virus is added to the surface of a culture plate that has been inoculated with suspicious anthrax colony growth, you can see clear zones where the B. anthracis cells have been destroyed-whereas other bacterial cells grow unaffected." Well before the anthrax attacks of 2001, scientists at USAMRIID and the CDC recognized the need for an FDA accepted method for identifying B. anthracis in clinical specimens. In 2002, FDA's Division of Clinical Laboratory Devices agreed to recognize tests for B. anthracis as eligible for classification with a 510(k) premarket notification process-the designation given to devices and other non-biologics. USAMRIID, with support from CDC, prepared and submitted a 510(k) Premarket Notification using both USAMRIID and CDC data on use of the gamma phage method. With FDA recognition of the assay as substantially equivalent to the classical assay used prior to 1976, it will be available for use for testing in designated civilian and military clinical laboratories. "This is a big first step in helping to provide the LRN labs with FDA cleared assays," said Judy Sheldon, a regulatory affairs microbiologist with the CDC's Bioterrorism Preparedness and Response Program. "The work done at USAMRIID and here at CDC provided a solid scientific basis for FDA to evaluate the assay performance. This work has set a high bar for other tests to meet." USAMRIID scientists standardized and validated the test to make it more rugged, more reproducible across laboratories, and more resistant to user error. They developed a clearly defined method for production of gamma phage that proved to be highly stable, as reflected in the extended shelf life of the B. anthracis-specific virus. USAMRIID then provided sufficient gamma phage material to CDC for distribution within the LRN, so that each laboratory will have the same material to be used in the test. In addition, USAMRIID developed Standard Operating Procedures for the assay to ensure that each laboratory in the LRN will run the test the same way. This also increases confidence in the final result. "This represents a very significant milestone for both of our organizations, in that all of the medical diagnostic products that we are developing must eventually follow a similar pathway for approval to allow clinical diagnosticians to use these tests to positively identify pathogens," said Colonel George W. Korch, Jr., commander of USAMRIID. "Successes such as these demonstrate that we can translate our research efforts into products for our health care providers and clinical laboratory professionals." US Army Medical Research Institute of Infectious D |
|||||||||||||||||||||
| Related Anthrax Current Events and Anthrax News Articles Milestone biodefense publication by Elsevier journal Vaccine Last week during the 'Vaccines for Biothreats and Emerging and Neglected Diseases Symposium' in Galveston TX, USA, the Elsevier journal Vaccine released a supplement dedicated to vaccines for biodefense. Cigarettes Harbor Many Bacteria Harmful to Human Health Cigarettes are "widely contaminated" with bacteria, including some known to cause disease in people, concludes a new international study conducted by a University of Maryland environmental health researcher and microbial ecologists at the Ecole Centrale de Lyon in France. New explanation for nature's hardiest life form Got food poisoning? The cause might be bacterial spores, en extremely hardy survival form of bacteria, a nightmare for health care and the food industry and an enigma for scientists. Better immune defense against anthrax Scientists discover a gene in anthrax-causing bacteria may help defend against this form of bio-warfare. Argonne researchers develop method that aims to stabilize antibodies Researchers at the U.S. Department of Energy's Argonne National Laboratory have developed a systematic method to improve the stability of antibodies. Early detection and quick response are key to defense against anthrax attack A large attack on a major metropolitan area with airborne anthrax could affect more than a million people, necessitating their treatment with powerful antibiotics. Data published in the New England Journal of Medicine support use of raxibacumab (ABthrax) for the treatment of inhalation anthrax Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced publication by the New England Journal of Medicine of the results of two pivotal animal efficacy studies, which showed the life-saving potential of the Company's human monoclonal antibody drug raxibacumab. One secret to how TB sticks with you Mycobacterium tuberculosis is arguably the world's most successful infectious agent because it knows how to avoid elimination by slowing its own growth to a crawl. Unexpected discovery can open a new chapter in the fight against tuberculosis A close relative of the microorganism that causes tuberculosis in humans has been found to form spores. Genetic switch potential key to new class of antibiotics Researchers have determined the structure of a key genetic mechanism at work in bacteria, including some that are deadly to humans, in an important step toward the design of a new class of antibiotics. More Anthrax Current Events and Anthrax News Articles |
|||||||||||||||||||||
|
|||||||||||||||||||||
|
|||||||||||||||||||||