Accelr8 Announces Study Results Projecting the Impact of Rapid Diagnosis on Choice of Initial Therapy in Serious Infections

Business Wire, Nov 4, 2008

DENVER -- Accelr8 Technology Corporation (Amex: AXK) announced today that research investigators at the Denver Health Medical Center presented results of a study using the company's BACcel[TM] rapid diagnostic system. They presented results of a retrospective study at the joint sessions of the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, www.icaac.org) and the Infectious Diseases Society of America (IDSA, www.idsociety.org), October 25-29 in Washington, DC. Connie S. Price, MD led the study. She is the Chief of Infectious Diseases, Denver Health, and Assistant Professor of Medicine at the University of Colorado School of Medicine. The purpose of the study was to estimate the potential impact of rapid diagnosis on reducing the use of suboptimal and inactive therapy caused by delays in obtaining results from standard lab cultures.

The investigators reviewed the charts of past patients who had contracted serious "Staph" infections and for whom frozen bacterial isolates were available for analysis. Using the medical charts, the investigators classified the therapy that had been administered to each patient while the physician was waiting for lab culture results. During this three-day wait, the physician did not know the identity of the causative organisms ("Staph") nor their antibiotic resistance (MRSA vs. susceptible Staph). However, the seriousness of the infections required the physician to start therapy without guidance from the lab. This type of prescription by judgment is known as "empiric therapy," and is known to have high failure rates with serious infections because of widespread and complex antibiotic resistance.

The investigators also analyzed the stored isolates using a prototype BACcel system, measuring the test's accuracy and speed in classifying MRSA and susceptible strains in the isolates that caused the original infections. They found the BACcel identification test had 100% sensitivity and 89% specificity in identifying MRSA within four hours of analysis of the isolates.

The investigators categorized the effectiveness of each empiric therapy that patients actually received. 46% of patients received appropriate therapy. 26% received useful therapy but also antibiotics that had excessively broad spectrum or unnecessary extra antibiotics. 27% of patients received therapy that was inactive against the causative organisms. They then projected that difference that rapid (same-day) results would have made in guiding the initial therapy, given the experimental test performance on the same isolates. They found that the projected rate of appropriate therapy would have risen from 46% to 97%, the rate for suboptimal/excess coverage would have fallen from 26% to 3%, and the rate for inactive prescribing would have fallen from 27% to zero.

The authors caution that the study was not a clinical trial, but a model for designing such a trial, and a guide to help estimate the required study size for a clinical trial.

According to Dr. Price, "We must now preserve the antibiotics we have for as long as possible, because new antibiotic development has almost stopped. Above all, we need to control the infection and avoid using drugs that are likely to fail. In addition, it's very important to avoid using drugs that have a spectrum that is broader than necessary to assure success for any particular patient. Good stewardship helps to preserve critical drugs that otherwise are becoming less useful over time as bacteria evolve and share new resistance mechanisms. Our study suggests that rapid diagnostics may represent a serious advance toward achieving these goals."

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. Accelr8 is developing rapid clinical pathogen platforms, the BACcel[TM], based on its innovative surface coatings, assay processing, and detection technologies. In addition, Accelr8 licenses certain of its proprietary technology for use in applications outside of Accelr8's own products.

Certain statements in this news release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements regarding future prospects and developments are based upon current expectations and involve certain risks and uncertainties that could cause actual results and developments to differ materially from the forward-looking statement, including those detailed in the company's filings with the Securities and Exchange Commission. Accelr8 does not undertake an obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events.