Accelerate Diagnostics Presents New Data at ECCMID 2022 Demonstrating Rapid and Accurate Results Using Automated Accelerate Arc™ Module and BC Kit

• New data shows the Accelerate Arc System enables automated and rapid sample preparation that yields robust reportability and accurate microbial identification for positive blood cultures using MALDI when compared to conventional MALDI methods

TUCSON, Ariz., April 25, 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 the release of new data on the Accelerate Arc Module and BC kit at the 32nd European Congress for Clinical Microbiology and Infectious Diseases (ECCMID) located in Lisbon, Portugal23-26 April 2022.

"The internal study data demonstrated 94% or greater accuracy on positive blood cultures processed using the Arc Module and BC kit, on the Bruker Biotyper and bioMérieux Vitek MS Systems when compared to conventional MALDI," said Shelley Campeau, PhD, D(ABMM), co-author of the studies and Director of Scientific and Clinical Affairs, Accelerate Diagnostics. "In addition, a study conducted at the Medical College of Wisconsin showed that Arc-processed samples* yielded 100% agreement, a majority of which had high confidence scores, when compared to conventional MALDI. This data represents an important step in providing a workflow solution to help automate sample preparation for rapid and accurate microbial identification, saving hours of wait time and numerous manual steps to deliver results."

The first study seeded samples for 20 of the most prevalent organism species (a total of 100 isolates) incubated on the BD Bactec FX blood culture system. After flagging positive, the samples were processed on the Arc BC kit and module, and subsequently tested in triplicate on both the Bruker Biotyper and bioMérieux Vitek MS MALDI systems, and results from Arc-processed samples were compared to conventional colony MALDI. The study found the Arc-processed samples had an overall agreement of 100% on the Bruker Biotyper, and 94% on the Vitek MS.

The second study conducted with the Medical College of Wisconsin processed 50 fresh positive blood cultures from the VersaTrek blood culture system on the Arc Module and were subsequently tested in triplicate on the Bruker MALDI system, with results from the Arc compared to conventional colony MALDI. The study found the Arc enabled direct identification of microorganisms in 90% of blood cultures, and there was 100% agreement between the Arc and colony identification. In addition, Arc enabled the identification in less than 90 minutes, with less than five minutes of hands-on time.

*Both studies were conducted using the Research Use Only Accelerate Arc BC Kit.

Two poster presentations featuring performance of the Accelerate Arc System will be presented on Monday April 25th, 12:00- 13:00 hr, Pavilion 3 of the Feira Internacional de Lisboa (FIL).

P1219 Analytical Performance of the Automated Accelerate Arc BC kit and Module for Direct Identification from Positive Blood Cultures using MALDI

Authored by: B. Mesich, D. Gerstbrein, A. Cruz, M. Faron, S. Campeau, and B. Buchan

P1039 Evaluation of the Accelerate Arc module and BC kit for isolation of microorganisms from positive blood culture broths and suitability for MALDI-ToF analysis

Authored by: A. Campos-Alvarez, S. Bolanos, K. Lank, R. Nyberg, S. Campeau, and C. Michel

For further information on the Accelerate Arc System at ECCMID, please visit Booth 1-31 at the Altice Arena exhibit space.

For more information on ECCMID, please visit their website at www.eccmid.org.

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.

"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.

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 any implication that the results of the new landmark study will be realized at other customers using the Accelerate Pheno system. 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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