Accelr8 Launches Clinical Specimen Study With Combined Test Methods
July 15 2009 - 8:00AM
Business Wire
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.�
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 a rapid analytical platform
for infectious pathogens, the BACcel� system, 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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