Working together to bring rapid, automated
microbial identification directly from positive blood culture
samples
TUCSON,
Ariz., Nov. 27, 2023 /PRNewswire/ -- Accelerate
Diagnostics, Inc. (NASDAQ: AXDX) an innovator of rapid in
vitro diagnostics in microbiology, announced the signing of a
collaboration and quality agreement with Bruker Corporation
(NASDAQ: BRKR), the provider of the market-leading MALDI Biotyper
system for microbial identification. This agreement enables both
companies to validate the use of Accelerate Diagnostics' Arc™
system, an innovative, automated positive blood culture sample
preparation platform, with Bruker's MALDI Biotyper®
sirius instruments and Sepsityper® software for
subsequent registration in both the US and EMEA markets.
Designed for clinical laboratories, the Arc™ system has a simple
load-and-go workflow that automates direct from positive blood
culture sample preparation for downstream microbial identification
using Bruker's MALDI Biotyper system. The Arc™ system enables
on-demand processing of samples without the need for an overnight
culture incubation, reducing the wait time for identification
results. Labs will be able to leverage the breadth of their Bruker
MALDI-Biotyper identification library in combination with rapid
phenotypic antibiotic susceptibility results using the Accelerate
Pheno® system, as well as with the Accelerate WAVE™
system which is currently under development and planned for future
release.
The Arc™ system is designed to compete with molecular positive
blood culture identification solutions. Namely, utilization of
Bruker's Biotyper system, in conjunction with the Arc™ system,
offers the potential to reduce the likelihood of cross reactivity
and false positive results that come with rapid molecular tests. In
addition, the platform economics are more favorable with the Arc™
system as compared to on-market molecular platforms, especially
when laboratories consider that approximately 30% of results are
blood culture contaminants resulting in wasted expense. Finally,
clinical laboratories are under pressure to run FDA cleared devices
with increased legislation and enforcement of laboratory developed
tests. As such, Accelerate has already initiated a clinical trial
with intent to submit to the FDA over the coming months with the
goal of seamless laboratory adoption.
"The total cost to rapidly identify organisms from positive
blood cultures is significantly lower than what labs are paying
today for a rapid molecular ID solution," said Jack Phillips, President and CEO of Accelerate
Diagnostics. "When you think of the extreme demand that labs are
under today, the Arc™ system is a fast and inexpensive diagnostic
tool which frees up technician hands and lab budgets to deliver
actionable results in the race against sepsis. We look forward to
working with Bruker, the recognized leader in mass
spectrometry-based microbial identification, to bring this much
needed solution to laboratories."
"The combination of Bruker's MALDI Biotyper with Accelerate
Diagnostics' Arc™ system to automate positive blood culture sample
preparation and rapid microbial identification will be a valuable
addition to many laboratories. Bruker welcomes this collaboration
with Accelerate Diagnostics as both companies are committed to help
laboratories in the important fight against sepsis with their
leading products" said Wolfgang Pusch, President, Bruker
Microbiology & Infection Diagnostics.
About Accelerate Diagnostics, Inc. (Nasdaq: AXDX)
Accelerate Diagnostics, Inc. is an in
vitro diagnostics company dedicated to providing solutions for
the global challenges of antibiotic resistance and sepsis. In
addition to its Arc™ system, the Accelerate Pheno®
system and Accelerate PhenoTest® BC kit combine
several technologies aimed at reducing the time clinicians must
wait to determine the most optimal antibiotic therapy for deadly
infections. The FDA cleared Pheno® system and kit fully
automate the sample preparation steps to report phenotypic
antibiotic susceptibility results in approximately 7 hours direct
from positive blood cultures. Recent external studies indicate the
solution offers results 1–2 days faster than existing methods,
enabling clinicians to optimize antibiotic selection and dosage
specific to the individual patient days earlier.
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and
"ACCELERATE PHENOTEST" and diamond shaped logos and marks are
trademarks or registered trademarks of Accelerate Diagnostics,
Inc.
For more information about the company, its products and
technology, or recent publications, visit axdx.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking or may have forward-looking implications, such as, among
others: intentions and expectations relating to the collaboration
and quality agreement with Bruker, including that the agreement
will enable both companies to validate the use of Accelerate
Diagnostics' Arc™ system with Bruker's MALDI Biotyper®
sirius instruments and Sepsityper® software for
subsequent registration in both the US and EMEA markets, as well as
the anticipated benefit for laboratories using the platforms in
conjunction; expectations regarding the potential or benefits of
Accelerate Diagnostics' products and technologies; expectations
regarding new or planned products and technologies, including the
anticipated timing of any releases, such as with respect to the
Accelerate WAVE™ system currently under development; and intentions
and plans relating to regulatory approvals or submission, including
with respect to the U.S. Food and Drug Administration (FDA). Actual
results or developments may differ materially from those projected
or implied in these forward-looking statements due to significant
risks and uncertainties, including, but not limited to general
industry and market conditions, such as volatility throughout the
global economy and the related impacts to the businesses of
suppliers and customers, whether due to customer demand
fluctuations, supply chain constraints and inflationary pressures
or otherwise, as well as Accelerate Diagnostics' ability to obtain
any regulatory approvals. Other important factors that could cause
Accelerate Diagnostics' actual results to differ materially from
those in its forward-looking statements include those discussed in
the company's filings with the Securities and Exchange Commission
(the "SEC"), including in the "Risk Factors" sections of the
company's most recently filed periodic reports on Form 10-K and
Form 10-Q and subsequent filings with the SEC. Except as required
by federal securities laws, Accelerate Diagnostics undertakes no
obligation to update or revise these forward-looking statements to
reflect new events, uncertainties or other contingencies.
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SOURCE Accelerate Diagnostics, Inc.