Accelr8 Announces Initial Results from ICU Pilot Clinical Study for Same-Day, Multi-Organism, Multi-Resistance Diagnostics Pr...
May 17 2011 - 7:00AM
Business Wire
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.”
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.
About Denver Health
Denver Health is the Rocky Mountain Region’s Level I academic
trauma center, and the safety net hospital for the Denver area. The
Denver Health system, which integrates acute and emergency care
with public and community health, includes the Rocky Mountain
Regional Trauma Center, Denver’s 911 emergency medical response
system, Denver Health Paramedic Division, eight family health
centers, 12 school-based health centers, the Rocky Mountain Poison
and Drug Center, NurseLine, Correctional Care, Denver CARES, Denver
Public Health, the Denver Health Foundation and the Rocky Mountain
Center for Medical Response to Terrorism, Mass Casualties and
Epidemics.
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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