Accelr8 Hosts Annual Shareholders' Meeting and Announces Key Development Milestones
DENVER, Dec. 14 /PRNewswire-FirstCall/ -- Accelr8 Technology Corporation (Amex: AXK) announced the results of internal pilot studies for its prototype rapid bacterial identification systems at its annual shareholders' meeting held in Denver. The studies are part of a major milestone in preparing to work with patient specimens. The company is developing the new BACcelr8r(TM) platform to rapidly analyze organisms that cause life-threatening infections in critically ill patients. In particular, Accelr8 initially targets ventilator associated pneumonia (VAP), the leading cause of mortality from hospital acquired infection (HAI). The US Centers for Disease Control and Prevention (CDC) estimates that at least 90,000 patients die each year from HAI. Of these, VAP mortality represents more than half. Medical experts believe that each of these cases of "attributable mortality" could have been treated successfully if adequate antibiotics had been started as initial therapy. Published sources estimate that approximately 300,000 confirmed cases of VAP occur annually in the US. The company plans to identify organisms that belong in each of three major antibiotic resistance categories. They cover most of the difficult forms of resistance encountered with VAP. The pilot studies provided initial demonstrations of success for the first two of these major categories. The first new method identifies strains of "MRSA," or methicillin resistant Staphylococcus aureus. News reports often refer to this type of bacterium as a "super-bug" because of its broad range of antibiotic resistance. It is a highly resistant form of the common bacteria that cause "Staph" infections. MRSA first emerged in the early 1960s, and has spread to now account for more than half of all hospital acquired Staph infections in most cities. The new test developed by Accelr8 identified the MRSA strain in less than three hours. The company's goal is six hours or less. Conventional tests typically require at least 24 hours, which is too late to help the physician assure adequate initial therapy. The second test identifies different organisms that resist important broad-spectrum antibiotics known as "beta-lactam" antibiotics. This second category includes strains that produce "extended spectrum beta-lactamase" enzymes, or ESBLs. This form of resistance has also spread rapidly and proliferated into hundreds of known variations and mixtures. The variation and complexity make this form of resistance difficult to detect accurately. This test also required less than three hours to complete, again with the goal of six hours or less. The company is not aware of any alternative method in development that competes with Accelr8 in identifying these organisms. The third analysis to be tested in upcoming studies is intended to identify the most resistant organisms seen in the hospital. The leading organisms in this category are species of Pseudomonas and Acinetobacter. Strains of these bacteria are spreading that are now susceptible to only one or two remaining antibiotics. The company has an objective of completing this test in less than 6 hours. As with the second category (ESBL), the company is not aware of any alternatives in development that compete with Accelr8 in identifying these organisms. S. aureus accounts for approximately 20% to 25% of VAP according to published statistics. Species that can carry the second type of resistance (ESBL) account for approximately 25% to 35% of VAP. Species associated with the third category account for approximately 30% to 40% of VAP and overlap those in the second category. Overall, the company believes that its first identification "panel" will cover approximately 75% of VAP-related species and a higher proportion of resistant strains. Almost all alternative "rapid" MRSA tests require cultured and purified strain isolates for identification, which typically take 6-24 hours to prepare. None of the commercially available MRSA tests provide results soon enough to guide initial therapy. With severe infections in critically ill patients, published research has shown that switching from inadequate to adequate as soon as the next day is too late to improve outcomes. Medical experts believe that rapid analysis of antibiotic resistance will lead to lower mortality and shorter, less expensive length of hospital stay. Current data show that infections by resistant organisms approximately double the mortality rate, double the length of stay, and double the cost when compared to infections by susceptible organisms of the same species in the same type of patient. New rapid MRSA gene tests that can work directly with uncultured specimens are approved only for screening people who carry the organism, and not for diagnosing infections. While this application has great potential and has attracted major investment, it does not address patients who actually have a life-threatening infection. Accelr8 is designing its system -- the BACcel(TM)-1.0 -- to eliminate culturing and strain isolation. It analyzes the bacteria extracted directly from patient specimens, thus eliminating the long delays inherent with culturing methods. It uses computerized microscopy to measure the responses of each individual bacterial cell to various tests. The test methods themselves use the same principles as standard tests, but optimized for single-cell analysis. The purpose of the BACcel-1.0 rapid identification is to help the physician avoid starting therapy with antibiotics that are the most likely to fail. It is not intended to guide specific drug choices. A later product version -- the BACcelr8r(TM) -- is planned to add specific drug data and provide the complete analysis. Accelr8's president, David Howson, said "we believe that these pilot studies are the first demonstration of methods that can quickly identify strains according to major resistance categories. Our methods eliminate the 6 to 24 hour delay of initial culture and strain isolation. The physician can receive the information soon enough to have a significant impact on adjusting the initial therapy. These pilot studies use standard reference strains that give us a clear baseline. We will now expand the challenges using recent, well-characterized isolates from patients who had respiratory infections." Howson continued "this year we are preparing to work with new patient specimens that we will analyze in our lab using our current research prototypes. These data sets will lay the groundwork for improved instruments to be placed into research labs." "Perhaps the most important point is that these studies are the first demonstration of new methods that can rapidly identify strains for more than one major resistance category. We believe that these methods will provide more accurate results and reach real patients more quickly than other new methods being developed. In particular, we use well-known analytical principles whereas most other new technology requires new discoveries and fundamental biological validation. Finally, our system can count organisms and report quantitative results, which is not possible with most of the other technology being developed." About Accelr8 Accelr8 Technology Corporation (www.accelr8.com) is a developer of innovative materials and instrumentation for advanced applications in medical instrumentation, basic research, drug discovery, and bio-detection. In addition to its microarraying products, Accelr8 is also developing a rapid clinical pathogen platform, the BACcelr8r(TM), based on its innovative surface coatings, assay processing, and detection technologies.
SOURCE Accelr8 Technology Corporation
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