Accelr8 Technology Corporation (NYSE Amex: AXK) announced that clinical investigators led by Ivor S. Douglas, MD/FRCP (UK) from Denver Health presented initial ICU pilot study results at the 2011 ATS International Conference. The American Thoracic Society (ATS, www.thoracic.org) is a leading organization for physician specialists in Pulmonary Medicine and Critical Care Medicine. ATS is holding its annual meeting this year in Denver, from May 13-18.
Dr. Douglas is the Chief of Pulmonary and Critical Care Medicine, and Director of the Medical Intensive Care Unit at Denver Health. The study was independently designed, conducted and analyzed by Dr. Douglas and co-author Connie S. Price, MD, Chief of Infectious Diseases, and Medical Director of Infection Control and Prevention at Denver Health. The study received in-kind and limited support from Accelr8, and a grant from NIH/NCRR Colorado Clinical and Translational Sciences Institute (CCTSI).
The study examined ICU specimens from patients at risk for developing pneumonia. But the study used a surveillance design, rather than waiting for symptoms to emerge before testing patient specimens. Investigators acquired bronch-alveolar lavage (BAL) specimens with a flexible telescoping plastic catheter ("mini-BAL") every other day to determine whether they could detect a new, emerging infection before symptoms arose. The goal was to determine whether early detection of a new infection could lead to a change in drug choices. Present standards of care require intensive care physicians to use a standard regimen of potent, broad-spectrum antibiotics without first having lab guidance. By the time culture results arrive (often 72 hours after treatment is started), the patient's outcomes are already determined. With rapid guidance, the physician might more accurately select therapy on the first day, or even before symptoms emerge. This capability should reduce treatment failures and help to avoid having to use days of costly, broad-spectrum drugs when they are not necessary.
The Denver investigators split each specimen between standard culturing and Accelr8's BACcel™ system. Culturing typically requires 3 days to report results. The BACcel™ system reported results in 4 - 6 hours after the lab received a specimen. The study achieved speed in two ways: first, by taking specimens prior to symptom emergence; second, by using the new BACcel™ technology. For this study, bedside clinicians were blinded to the BACcel™ results but received the results of conventional microbiology testing to guide treatment.
Of 35 patients studied with 77 specimens, 9 patients were positive for pneumonia by microbiological criteria from culturing or from the BACcel™ result. One patient tested negative with standard culturing but was diagnostically positive for pneumonia by CDC clinical criteria. The BACcel™ system detected an important pathogen in this patient, near to the quantitative diagnostic threshold. Although the BACcel™ result disagreed with culturing, it agreed with clinical criteria and yielded a correct, early diagnosis that culturing missed.
In this pilot study, overall diagnostic sensitivity was 86% and specificity was 97%, after analyzing for the presence of any of three target organisms and major drug resistance types for each. Targets include Staphyolococcus aureus ("Staph," including "MRSA"), Pseudomonas aeruginosa, and Acinetobacter species. All of these targets are potentially multi-drug resistant "superbugs," and are major threats in the ICU. According to the authors, the BACcel™ system delivered results 40 to 66 hours faster than culturing. The BACcel™ system tested multiple target species and multiple drug resistance types at the same time, unlike molecular diagnostic techniques.
The investigators also found that in 63% of cases patients were prescribed potentially ineffective therapy because medications were prescribed prior to receiving laboratory results. Historical attempts to achieve early detection used cultures started before symptoms appeared. Most other studies have had to compare patients in retrospect: those who happened to receive effective drugs compared with similar patients who received inadequate therapy.
Even with culture-based approaches, the 2-3 day delay still precludes guidance during the narrow window that experts believe may offer the best possible result. BACcel™ technology made the Denver study possible.
As Dr. Douglas explained, "our research demonstrates that same-day, broad-coverage diagnosis for serious infection in high-risk patients is within reach. The research design represents a new paradigm for studying serious ICU infections. Reliable quantitative information about viable bacterial infection and antibiotic sensitivity that informs treatment decisions in the critically ill is feasible. The surveillance and rapid diagnosis make it possible to conduct well-designed studies to determine the clinical value of this new paradigm in managing critically ill patients."
According to David Howson, Accelr8's president, "this first set of results from an independent prospective clinical study marks tremendous progress in our BACcel™ development. It establishes a landmark for same-shift multi-bug and multi-drug analysis applied directly to specimens from high-risk ICU patients. It also sets the stage for the next generation of prototype instrument. The next generation is now on a fast development track. With this next automated platform, we plan to widen our clinical study network to additional key opinion leaders and expand our evidence base. Our unique product strategy sets the BACcel™ system apart from other attempts to address the escalating crisis of multi-resistant infections."
Accelr8 Technology Corporation