Accelerate Diagnostics Announces a Successful Completion of its WAVE™ Pre-Clinical Trial
It is estimated by the
"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
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:
Antibiotic Class |
Drugs |
All Gram Negative |
|
EA% |
CA% |
||
Carbapenems |
Ertapenem, Meropenem |
97.0 |
98.2 |
B-lactam combos |
Amoxicillin/clavulanate, Ampicillin/sulbactam, Ceftolozane/tazobactam, Ceftazidime/avibactam, Piperacillin/tazobactam |
94.8 |
92.7 |
Aminoglycosides |
Amikacin, Gentamycin, Tobramycin |
92.8 |
96.5 |
Cephalosporins |
Ceftazidime, Cefazolin, Cefuroxime, Ceftriaxone, Cefepime |
94.0 |
93.0 |
Fluroquinolones |
Ciprofloxacin, Levofloxacin |
96.0 |
96.5 |
Monobactams |
Aztreonam |
98.9 |
94.4 |
Sulfonamides |
Trimethoprim/sulfamethoxazole |
94.9 |
94.9 |
Penicillin |
Ampicillin |
95.6 |
100 |
(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,
2 Murray CJ. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis.
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
The "
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/accelerate-diagnostics-announces-a-successful-completion-of-its-wave-pre-clinical-trial-302218348.html
SOURCE