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
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
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
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."
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