Accelerate Diagnostics achieves CE-IVD milestone for severe bacterial pneumonia assay, doubles revenue for 2017 in Q4
January 10 2018 - 7:57AM
Accelerate Diagnostics, Inc. announced today its declaration of
conformity to the European In Vitro Diagnostic Directive 98/79/EC
and CE mark of its latest assay for the Accelerate Pheno™ system
targeting severe bacterial pneumonia infections. During the related
study, results for the severe pneumonia assay were available about
57 hours faster than the standard of care.
In addition, the company announced preliminary revenue for the
fourth quarter of 2017 of $2.1 million, a 52 times increase over
the fourth quarter of 2016. Preliminary revenue for the full year
of 2017 is estimated at $4.2 million, a 16 times increase over the
prior year. Instruments under agreement increased by 42 in the
fourth quarter bringing the total of instruments under customer
agreement to 337.
Financial results for the full year and quarter ending December
31, 2017 will be filed through the Securities and Exchange
Commission's (SEC) website at http://www.sec.gov. Investors are
cautioned not to place undue reliance on these preliminary
estimates in the event of material changes.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (Nasdaq:AXDX), is an in vitro
diagnostics company dedicated to providing solutions for the global
challenge of antibiotic resistance and healthcare-associated
infections. The company recently obtained FDA marketing
authorization for antimicrobial susceptibility testing direct from
positive blood culture samples using its Accelerate Pheno™ system
and Accelerate PhenoTest™ BC kit. The system and kit leverage
proprietary molecular identification methods and morphokinetic
cellular analysis (MCA) to provide minimum inhibitory
concentrations for a range of applicable antibiotics. The
fully-automated system is designed to eliminate the lengthy culture
and sample preparation steps required prior to antimicrobial
susceptibility testing. Recent market studies suggest the solution
offers results 1-2 days faster than conventional methods, enabling
clinicians to optimize antibiotic selection, dosage, and infusion
strategy specific to the individual patient and their
infection.
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 or
technology, visit http://axdx.com.
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, such as the
ongoing commercial launch, demand, and potential of our products or
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 February
28, 2017, and in any other reports that we file with
the Securities and Exchange Commission from time to time.
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.
Investor and media contact:Andrew Chasteen,
Accelerate Diagnostics, +1 520 365-3100achasteen@axdx.com
Source: Accelerate Diagnostics, Inc.
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