Accelr8 Announces Study Results Projecting the Impact of Rapid Diagnosis on Choice of Initial Therapy in Serious Infections
November 04 2008 - 8:00AM
Business Wire
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� 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�, 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.
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