NEW YORK – Accelerate Diagnostics announced Friday that it has submitted its Accelerate Wave system and positive blood culture Gram-negative test kit to the US Food and Drug Administration for 510(k) approval.
The Wave platform is designed to provide rapid antimicrobial susceptibility testing directly from positive blood culture bottles and bacterial isolate colonies in 4.5 hours on average, the Tucson, Arizona-based firm said in a statement.
The system is intended to “support earlier, targeted antimicrobial therapy—improving patient outcomes, reducing hospital costs, and helping combat antimicrobial resistance,” the company added.
Accelerate Diagnostics completed its preclinical trial for the Wave platform last year, achieving its goals of essential and categorical agreement with broth microdilution of approximately 95 percent. Essential agreement was between 93 percent and 99 percent for all of the antibiotic classes tested, while categorical agreement ranged from 93 percent to 100 percent.
The company currently markets the Pheno system for antimicrobial susceptibility testing and Arc Module for automated, rapid microbial identification of positive blood cultures.
Separately on Friday, the firm announced its Q4 and full-year 2024 financial results. Accelerate reported that net sales for Q4 declined 7 percent to $2.8 million from $3.0 million in Q4 2023, primarily driven by lower sales of consumable products compared to 2023. Net loss for the quarter was $9.6 million, or $.38 per share, compared to net loss of $13.0 million, or $.89 per share, in Q4 2023.
Sales for full-year 2024 declined 3 percent to $11.7 million from $12.1 million in 2023 as the result of a “challenging capital sales environment in all our sales regions,” the company said. Consumable products revenue rose 3 percent year over year.
Net loss for the year was $50.0 million, or $2.15 per share, compared to net loss of $61.6 million, or $4.94 per share, in 2023.
Accelerate ended the quarter with approximately $16.3 million in cash and cash equivalents.