Accelerate Diagnostics Announces CE Mark and Availability in Europe of Fast Antimicrobial Susceptibility Test for Use with Existing ID Systems

Rhea-AI Summary

Accelerate Diagnostics (NASDAQ:AXDX) announces the CE marking of its new IVD configuration of the Accelerate PhenoTest® BC kit, now ready for use in Europe. This expansion follows its U.S. launch in July and provides fast antimicrobial susceptibility testing results in approximately 7 hours from positive blood cultures. The Pheno system has shown to improve clinical outcomes, including reduced hospital stays. The new configuration offers flexible workflow options for diverse laboratory settings across Europe.

Positive

• CE marking of the new IVD configuration expands market opportunities in Europe.
• Accelerate PhenoTest BC kit provides antimicrobial susceptibility testing results in approximately 7 hours, enhancing clinical efficiency.
• Improved clinical outcomes have been reported, including reduced time to optimal therapy and hospital length of stay.

Negative

• None.

TUCSON, Ariz., Aug. 3, 2021 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ:AXDX) today announced that the new IVD configuration of its Accelerate PhenoTest^® BC kit has been CE marked and is ready for use in Europe.

The new configuration, which launched in the United States in July, provides fast antimicrobial susceptibility testing (AST) results in approximately 7 hours direct from positive blood cultures and is designed to run on the Accelerate Pheno^® system as a flexible solution for laboratories that already have a rapid identification system. This is an important new option for the Company's existing Accelerate PhenoTest BC kit, which already had an ID/AST configuration that is a fully integrated solution for labs needing both fast identification and fast AST.

The Accelerate Pheno system has been shown to deliver improvements in clinical outcomes including time to results, time to optimal therapy, duration of therapy and hospital length of stay.*

"This product expansion provides fast phenotypic, MIC-based AST results and unique flexible workflow options to accommodate the different clinical and laboratories settings across Europe," said Cherif Bousselham, senior vice president, head of sales, EMEA, for Accelerate Diagnostics.

* A selection of outcomes data is available at results.axdx.com and a complete database of scientific publications can be found at axdx.com/publications.

About Accelerate Diagnostics, Inc.

Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. 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 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 have forward-looking implications. 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 2, 2021, and in any other reports that the company files with the Securities and Exchange Commission. The company's forward-looking statements could be affected by general industry and market conditions, and regulatory approvals. 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.

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SOURCE Accelerate Diagnostics, Inc.

FAQ

What is the latest announcement from Accelerate Diagnostics regarding the AXDX stock?

Accelerate Diagnostics announced the CE marking of its new IVD configuration of the Accelerate PhenoTest BC kit for use in Europe.

When was the Accelerate PhenoTest BC kit launched in the United States?

The Accelerate PhenoTest BC kit was launched in the United States in July 2021.

What are the benefits of the Accelerate PhenoTest BC kit?

The kit provides antimicrobial susceptibility testing results in approximately 7 hours and improves clinical outcomes.

How does the Accelerate Pheno system impact clinical outcomes?

The system reportedly reduces time to results, optimal therapy, and hospital stays.