AXDX Accelerate Diagnostics Inc

TUCSON, Ariz., Aug. 8, 2024 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ: AXDX) an innovator of rapid in vitro diagnostics in microbiology, announced the successful completion of its WAVE pre-clinical trial. The Accelerate WAVE system is designed to deliver rapid antimicrobial susceptibility testing ("AST") directly from positive blood culture ("PBC") bottles and bacterial isolated colonies ("Isolates") to report accurate results within 4.5 hours, on average.

It is estimated by the World Health Organization, Sepsis affects an estimated 49 million¹ people globally each year, causing an estimated 11 million¹ deaths of which an estimated 1.3² million are attributed to bacterial antimicrobial resistance. Additionally, Sepsis is the number one cost to the US healthcare system with an annual estimated expense of $62 billion³. By delivering rapid AST results, patients with serious infections can be put on targeted antimicrobial therapy to improve patient outcomes, cut hospital costs, and reduce antimicrobial resistance.

"We are extremely pleased to announce the goals for our WAVE pre-clinical trial were achieved with strong performance and unprecedented time-to-result of 4.5-hours, on average, along with strong instrument reliability and assay reportability," commented Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. "With the success of the pre-clinical trial we have confidence in both our WAVE product design and the system capabilities to move to a clinical trial and in turn commercialize." Mr. Phillips continued. 

The pre-clinical trial included 1,570 WAVE results compared to Broth Microdilution ("BMD"), the reference method. The trial included an equal number of prospective patient samples and site selected challenge samples which resulted in excellent concordance between sample types. Summary performance concluded overall Essential Agreement ("EA") and Categorical Agreement ("CA") of approximately 95%. See below for a summary of performance by antibiotic class

Summary of Pre-clinical Data Performance by Antibiotic Class: 

(1) GN Organisms include: Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae. Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa and Serratia marcescens. 

References:

1 Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

2 Murray CJ. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0.

3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017950/)

About the Accelerate WAVE System:

The Accelerate WAVE system is intended to deliver same-shift antibiotic susceptibility test results enabling antimicrobial stewardship teams and clinicians alike to tailor therapy for patients with serious infections in a timely manner. Getting the patient on optimal therapy, as shown with numerous peer-reviewed publications, not only reduces morbidity associated with bacteremia but also reduces healthcare costs.  

The WAVE system will offer a comprehensive test menu and incorporates essential features to optimize workflow across laboratories. With full random access for continuous sample loading, the scalability of the Wave system addresses the needs of various health care settings from small community hospitals to large academic centers and reference labs. The WAVE System employs novel holographic imaging technology to determine bacterial growth and morphology changes in real time, enabling same-shift, quantitative susceptibility test results. 

About Accelerate Diagnostics, Inc. (Nasdaq: AXDX) 

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 "ACCELERATE ARC" and "ACCELERATE WAVE" 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 https://acceleratediagnostics.com/. 

Forward-Looking Statements

Certain of the statements made in this press release are forward-looking or may have forward-looking implications within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the company intends that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements, which can be identified by the use of words such as "may," "will," "expect," "believe," "anticipate," "estimate," or "continue," or variations thereon or comparable terminology, include but are not limited to, statements about: expectations regarding the potential or benefits of the WAVE system, including the belief that the WAVE system and Gram-Negative Positive Blood Culture (PBC) assay can be seamlessly run within an external customer clinical microbiology lab with trained operators, the belief that the WAVE system has the potential to deliver improved patient outcomes for hospitals given its scalability and high-throughput design, and the expectation of the performance of the WAVE system based on pre-clinical trials; expectations regarding new or planned products and technologies, including the anticipated timing of any releases, such as with respect to the WAVE system; and intentions and plans relating to regulatory approvals or submission, including with respect to the U.S. Food and Drug Administration (FDA). Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to significant risks and uncertainties, including, but not limited to: volatility throughout the global economy and the related impacts to the businesses of the company's suppliers and customers, whether due to customer demand fluctuations, supply chain constraints and inflationary pressures or otherwise; difficulties in resolving the company's continuing financial condition and ability to obtain additional capital to meet its financial obligations; the company's ability to obtain any regulatory approvals; and less than expected operating and financial benefits resulting from cost cutting measures. Other important factors that could cause the company's actual results to differ materially from those in its forward-looking statements include those discussed in the company's filings with the Securities and Exchange Commission (the "SEC"), including in the "Risk Factors" sections of the company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. These forward-looking statements are also based on certain additional assumptions, including, but not limited to, that the company will retain key management personnel; the company will be successful in the commercialization of its products; the company will obtain sufficient capital to commercialize its products and continue development of complementary products; the company will be successful in obtaining marketing authorization for its products from the FDA and other regulatory agencies and governing bodies; the company will be able to protect its intellectual property; the company's ability to respond effectively to technological change; the company's ability to accurately anticipate market demand for its products; and that there will be no material adverse change in the company's operations or business and general market and industry 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. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing the company's plans and expectations as of any subsequent date.

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SOURCE Accelerate Diagnostics, Inc.