EndocrinologyAccelr8 Launches Clinical Specimen Study With Combined Test Methods
Accelr8 Technology Corporation (NYSE Amex:AXK) announced the start of a comprehensive study that integrates its BACcel™ test methods using respiratory clinical specimens from ICU patients. Accelr8"s scientists had previously developed each of its test methods using cultured strains. Development then progressed to clinical specimens, focused on optimizing each individual step. The next stage of combining the steps begins with the new study. The study will test ICU respiratory specimens and compare results with those from standard culturing methods (the "gold standard" for testing). Study completion will constitute a major technical milestone toward commercialization.
The study required expanded specimen access through the company"s institutional research collaborators in Denver (Denver Health Medical Center) and St. Louis (Barnes-Jewish Hospital). The new study also supports an ICU surveillance study previously announced with Denver Health. The surveillance study was recently cleared by the governing Institutional Review Board and will now proceed.
According to clinical laboratory experts, the type of respiratory specimen used in these studies has perhaps the greatest variability and complexity of all specimen types. Therefore success with these specimens would help convince hospital lab directors that the BACcel™ system appears commercially achievable.
Pneumonia is the leading infectious cause of mortality and prolonged stay in the ICU. Respiratory specimens used to diagnose pneumonia thus offer the most important path to proving value for the BACcel™ system.
The BACcel™ system is being developed to quantify and identify pathogenic species that are most likely to harbor multiple antibiotic resistance mechanisms, which often cause initial therapy to fail in the absence of specific lab guidance. Previous studies have shown that the BACcel™ system is capable of organism quantitation and identification within two hours of specimen access. It has also shown the ability to characterize antibiotic resistance within a total of six hours after specimen access. Standard culturing now typically requires 2-3 days, which is too late for managing critically ill patients who become infected with a dangerous pathogen.
Other new technology for rapid testing has been limited to identifying a very small number of species and only a single type of drug resistance in each. These devices are useful for screening patients who enter the hospital carrying dangerous organisms such as MRSA, a type of drug-resistant "Staph." However, application to patients with active infections requires much broader coverage of species and resistance mechanisms. As shown in recent research publications, inherent biological complexity appears to limit these popular molecular marker methods to a minority of pathogens. Treatment decision support requires a substantially larger and more adaptable test inventory.
Accelr8 is developing the BACcel™ system to close that gap. The CDC estimates that almost 99,000 US patients needlessly die each year from hospital-acquired infections (HAI), despite the fact that an antibiotic exists that should cure each of these infections. Lab delays force the physician to guess which antibiotics to use, and this type of "empiric" therapy typically fails about one-third of the time. HAI also causes tens of billions of dollars in excess hospital costs each year because of extended ICU and total hospital length of stay. Medical experts project that reducing the failure rate of initial therapy would reduce morbidity and mortality from serious infections, and also reduce the excess costs estimated to now average $20,000 to $80,000 per case of HAI. The company believes that its unique platform should reduce treatment failures by providing specific guidance within the short time available to start effective therapy.
According to David Howson, Accelr8"s president, "the new study will take us to a new level in making our case for technical success, and also support our initial thrust into real-time pilot application studies. We"re excited about advancing our technology into field demonstrations directly with critical specimens. This new milestone is consistent with other milestones in our technical development agreement, which we have been meeting. To the best of our knowledge, no other technology has demonstrated the ability to identify multiple species and multiple resistance types within a few hours of receiving a patient specimen."
Accelr8 Technology Corporation