Accelerate Diagnostics Submits De Novo Request to FDA for Accelerate Pheno™ System and Accelerate PhenoTest™ BC kit
July 11 2016 - 5:00AM
Accelerate Diagnostics, Inc. (“Accelerate”) announced today the
submission of a De Novo request for Evaluation of Automatic Class
III Designation to the U.S. Food and Drug Administration (FDA) for
its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for
positive blood culture samples.
The fully automated system provides high-speed identification
(ID) and antimicrobial susceptibility testing (AST) of pathogens
from patient samples faster than conventional methods. In recently
completed marketing studies, the system and kit saved more than 40
hours as compared to standard of care methods; creating the
potential to expedite optimal antimicrobial therapy for patients
suspected of bacteremia or fungemia, both life-threatening
conditions with high morbidity and mortality risk.
The Accelerate PhenoTest™ BC kit consists of a highly
multiplexed panel of assays targeting the most prevalent
microorganisms and the antimicrobial agents typically used to treat
them. Accelerate anticipates launching the BC kit with 140
individual assays. The final number of assays included in the kit
distributed in the U.S. will depend on the review of each
individual assay for marketing authorization by the FDA.
The De Novo request, sent Friday evening to the FDA, is
supported by a recently completed clinical study including more
than 1,800 samples across 13 study sites. Overall results across
all assays from the study showed 97.4% sensitivity and 99.3%
specificity for ID results and 95.1% essential agreement and 96.0%
categorical agreement for AST.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (“Accelerate Diagnostics,”)
(Nasdaq:AXDX), is an in vitro diagnostics company dedicated to
providing solutions for the global challenge of antibiotic
resistance and hospital acquired infections. The company's fully
automated ID/AST system, Accelerate Pheno™, and direct from
positive blood culture kit, Accelerate PhenoTest™ BC, utilize
proprietary molecular and phenotypic detection technologies which
have the potential to substantially reduce the time to
antimicrobial susceptibility results while achieving high
sensitivity and specificity. For more information about Accelerate
Diagnostics, visit http://www.acceleratediagnostics.com.
The “ACCELERATE DIAGNOSTICS” and “ACCELERATE PHENO” and
“ACCELERATE PHENOTEST” logos and marks are trademarks or registered
trademarks of Accelerate Diagnostics, Inc.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, about our projections as to
when certain key business milestones may be achieved, including
marketing authorization by the FDA of the Accelerate Pheno™ system
and Accelerate PhenoTest™ BC kit for positive blood cultures, the
commercial launch of the Accelerate Pheno™ system and Accelerate
PhenoTest™ BC kit for positive blood cultures, the potential of our
technology, the growth of the market, our estimates as to the size
of our market opportunity and potential pricing, our competitive
position and estimates of time reduction to results, and our future
development plans and growth strategy. Actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Information about the risks
and uncertainties faced by Accelerate Diagnostics is contained in
the section captioned “Risk Factors” in the company's most recent
Annual Report on Form 10-K, filed with the Securities and Exchange
Commission on March 9, 2016. In addition, the company's
forward-looking statements could be affected by general industry
and market conditions. Except as required by federal securities
laws, the company undertakes no obligation to update or revise
these forward-looking statements to reflect new events,
uncertainties or other contingencies.
CONTACT
Media Contact:
Andrew Chasteen
+1 (520) 365 3100
achasteen@axdx.com
Investor Contact:
Laura Pierson
+1 (520) 365 3100
investors@axdx.com
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