Accelerate Diagnostics announces commercialization of its Accelerate Arc™ system having completed IVD registration with FDA

Rhea-AI Summary

Accelerate Diagnostics, Inc. (NASDAQ: AXDX) announced the commercialization of its Accelerate Arc Module and BC kit, aimed at automating microbial identification for positive blood cultures. This system significantly reduces wait times and labor while offering cost savings for healthcare facilities. Registered as an IVD with the FDA, the system is designed for labs using MALDI platforms and requires minimal hands-on time. It allows for faster reporting of identification and antimicrobial susceptibility results, enhancing the efficiency of clinical workflows.

Positive

• FDA registration of Accelerate Arc Module opens U.S. market opportunities.
• Automated workflow reduces labor and wait times significantly.
• Potential for cost savings in healthcare facilities using the product.

Negative

• None.

Commercialization of Accelerate Arc system, which includes the Accelerate Arc Module and BC kit, unlocks the path to automated, rapid microbial ID for positive blood cultures across the large installed base of MALDI system users. The Accelerate Arc system can cut hours of wait time, eliminate laborious hands-on sample prep, and offer significant cost savings for healthcare facilities compared to current methods.

TUCSON, Ariz., May 16, 2022 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ: AXDX) an in-vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis, today announced commercialization of its new Accelerate Arc Module and BC kit.

"On the heels of publishing robust data at the 32nd European Congress for Clinical Microbiology and Infectious Diseases demonstrating the value of using the automated Accelerate Arc Module and BC kit, we're excited to announce this product is now registered as an IVD with the FDA and will soon be available to healthcare facilities in the U.S. market," said John Meduri, Chief Strategy Officer for Accelerate Diagnostics. "Arc in its early days of commercialization has already generated numerous evaluations and in-bound interest from potential commercial partners. Using our system, the total cost to rapidly identify organisms from positive blood cultures is significantly less than what laboratories are paying today for a rapid molecular ID solution."

Designed for labs with MALDI platforms, the Accelerate Arc Module and BC kit is a novel application of inline centrifugation and automated sample prep techniques, which together with the blood culture (BC) kit, provides a suspension of cleaned microbial cells for direct transfer to a MALDI spotting plate.

The simple load-and-go workflow eliminates the need for batching multiple specimen tests, cutting hours off the wait for microbial ID results for positive blood cultures. The Accelerate Arc Module requires just 2-3 minutes of hands-on time to run and is simple enough to be used on all shifts, by any laboratory technician, freeing up valuable technician time by automating the MALDI workflow. Further, this automated, rapid workflow that the Accelerate Arc system avails is the perfect companion to the Accelerate PhenoTest^® BC kit AST configuration enabling laboratories to report identification and antimicrobial susceptibility test results directly from positive blood cultures days earlier than current standard-of-care methods.

For further information on the Accelerate Arc Module, please visit the Accelerate Diagnostics products page linked here.

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 Arc™ Module and BC kit is an innovative technology that offers an automated path to direct MALDI identification for positive blood cultures and requires a simple workflow with short hands-on-time. This new sample prep device enables lab technicians to easily unlock the vast ID capability of MALDI.

"Accelerate Diagnostics" and diamond shaped logos and marks are registered trademarks of Accelerate Diagnostics, Inc. Any trade, product or service name referenced in this document using the name "Accelerate" is a trademark and/or property of Accelerate Diagnostics, Inc. All other company and product names may be trademarks, registered trademarks, or service marks of the companies with which they are associated. 

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. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Such forward looking statements include, but are not limited to, statements regarding expected customer cost savings, and improvements in workflow times. 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 14, 2022, 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 Accelerate Arc Module announced by AXDX?

The Accelerate Arc Module is a new system for automated microbial identification from positive blood cultures.

When was the Accelerate Arc Module registered with the FDA?

The Accelerate Arc Module was registered as an IVD with the FDA on May 16, 2022.

What benefits does the Accelerate Arc Module provide to healthcare facilities?

It reduces wait times for microbial identification and offers significant cost savings compared to current methods.

How does the Accelerate Arc Module improve laboratory workflows?

It automates sample preparation and requires only 2-3 minutes of hands-on time, streamlining the identification process.

What are the expected market impacts of the Accelerate Arc Module for AXDX?

The commercialization of the module is expected to enhance market penetration and drive potential revenue growth.