Accelr8 4-Hour Test Identifies New Drug-Resistant “Staph” (hVISA) Undetectable by Hospital Labs
May 23 2011 - 7:00AM
Business Wire
Accelr8 Technology Corporation (NYSE Amex: AXK) announced
results from two studies presented at ASM 2011 (American Society
for Microbiology, www.asm.org) held in New Orleans. Authors
included principal investigators from Denver Health and from the
Barnes-Jewish Hospital in St. Louis. The annual ASM General Meeting
is a major international congress for microbiologists and
Infectious Diseases physicians.
One study screened 281 randomly collected clinical specimens and
identified 62 for complete detailed analysis of pathogen content.
The purpose was to test the accuracy and timing for BACcel™ rapid
diagnostic assays intended for use with critically ill patients who
acquire serious infections. The BACcel™ system eliminates culturing
and analyzes individual live microbial cells directly from a
patient specimen. All specimens came from the lower respiratory
tract, used to diagnose pneumonia and other severe lung or
bronchial infections. Hospital acquired pneumonia is the leading
infectious cause of death in ICUs.
The study targeted three major pathogenic bacterial species
responsible for infections multi-drug resistance (MDR). Together,
these three species account for more than half of hospital acquired
MDR infections. They include Staphylococcus aureus (“Staph,”
including MRSA), Pseudomonas aeruginosa, and Acinetobacter species.
The latter two organisms already have high MDR propensity. But
investigators are now finding new strains that recently acquired
novel, rapidly-spreading “superbug” KPC genes from entirely
unrelated species.
The new ASM study reported that the total time from specimen to
results only required 4 hours, instead of the typical 3-day time
for cultures using the same specimens. Results included organism
counts, identification, and expression of two major resistance
types for each one, including MRSA. Identification was correct in
182 of 186 tests, and antibiotic resistance classification in 31 of
32 tests.
The second study characterized Accelr8’s new test for a hidden
type of resistance in “Staph.” Not only MRSA, but also the more
common type of Staph can effectively resist the standard anti-MRSA
antibiotic, vancomycin. With a new type of strain known as hVISA,
culturing tests indicate susceptibility to vancomycin, but fails to
detect subtle indications of low-level resistance that can lead to
treatment failure. Microbiologists refer to this type of cryptic
behavior as “heteroresistance.”
The investigators screened Staph clinical isolates (laboratory
strains) and found 15 hVISA using complex culturing methods. The
new BACcel™ assay correctly classified 14 of the 15 as hVISA, and
14 of 14 Staph clinical isolates negative for cryptic
resistance.
Culturing methods to detect hVISA take 3 days or longer,
depending on the methods. The BACcel™ system produced results in 4
hours. The test can be used directly from patient specimens, which
would add no more than 1 hour to the total processing time.
According to David Howson, Accelr8’s president, “the specimen
study used types of specimen that may be the most difficult
specimens for a lab to analyze. They are highly variable, and
contain large amounts of sticky and bulky interfering materials. In
the past, new diagnostic tests that have worked well with cultured
strains often failed when challenged directly with respiratory
specimens. We believe this study demonstrates that we’ve overcome
this major hurdle. The study also set a new speed record for
counting, identifying, and analyzing multiple targets with multiple
resistance tests—only four hours after starting with a specimen. If
we consider these results and the results presented a week ago at
ATS, the combined data show that the BACcel™ rapid diagnostic
system is accurate and very fast.”
“The hVISA study also follows a presentation three weeks ago at
the European ECCMID meeting that used the BACcel™ hVISA test, along
with others. The new results add details that more fully
characterize the test performance with this difficult new strain.
The ASM study demonstrates the BACcel™ system’s potential for
revealing fundamental modes of resistance expression that were
neither predicted nor detected using standard culturing methods,”
Howson continued.
“These and other tests for multiple organisms and multiple
resistance expression modes provide the platform for expanded
studies and integration into the next BACcel™ generation. We are
now widening our key opinion leader network to prepare for these
important studies,” Howson concluded.
Downloadable copies of presentations are available on the
publications page of Accelr8’s Web site at
www.accelr8.com/pgen.php?pg=resources_publications.
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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