TUCSON, Ariz. - Accelerate Diagnostics, Inc. (NASDAQ:AXDX) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Accelerate Arc system and BC kit, the company announced today. This clearance paves the way for clinical laboratories to utilize the system with the Bruker (NASDAQ:BRKR) MALDI Biotyper® CA System (MBT-CA System) and its MBT-CA Sepsityper® extension for swift microbial identification directly from positive blood culture samples.
The Accelerate Arc system is designed to automate the preparation of positive blood culture samples, which traditionally require overnight culture methods. By doing so, it significantly reduces the time needed for microbial identification, a crucial factor in the management of sepsis and in combating antimicrobial resistance (AMR).
The system utilizes the extensive reference library of the Bruker MBT-CA to provide rapid identification (ID) of pathogens. When used alongside the upcoming Accelerate WAVE™ system, which is currently under development, the Accelerate Arc system is expected to enable same-shift reporting of ID and antibiotic susceptibility testing (AST) results to clinicians. This rapid delivery of results can help improve patient outcomes, reduce antimicrobial resistance rates, and cut hospital costs by ensuring patients receive the most effective antibiotic therapy sooner.
The FDA clearance is particularly significant for clinical laboratories that have been under increased legislative pressure to use FDA-cleared devices instead of Laboratory Developed Test (LDT) sample preparation methods. The Accelerate Arc system offers an automated, FDA-cleared alternative.
Jack Phillips, President and CEO of Accelerate Diagnostics, expressed optimism about the system's role in enhancing patient care, stating that the FDA clearance "marks the beginning of an exciting journey in our broader innovation roadmap."
The Accelerate Diagnostics portfolio also includes the FDA-cleared Accelerate Pheno system and Accelerate PhenoTest® BC kit, which automate sample preparation, identification, and phenotypic antibiotic susceptibility testing. These systems can deliver results 1-2 days faster than existing methods, potentially allowing clinicians to tailor antibiotic therapy to individual patients more quickly.
This announcement is based on a press release statement from Accelerate Diagnostics, Inc.
In other recent news, Accelerate Diagnostics Inc . has regained compliance with Nasdaq's minimum Market Value of Listed Securities requirement, closing the matter of potential delisting. This development comes after the company's common stock market value remained at or above the $35 million threshold for ten consecutive business days. In addition to this, the company has made significant strides in its Wave program, aimed at transforming the microbiology susceptibility testing market. The successful completion of a preclinical trial for its second-generation antimicrobial susceptibility system has been announced.
Despite reporting a net loss of $11.6 million for the second quarter of 2024, with net sales of $3 million and a gross margin of 23%, Accelerate Diagnostics has secured funding to continue its operations and the Wave program through 2025. The company is also implementing measures to reduce operating expenses and cash burn in anticipation of clinical trials and regulatory clearances. Furthermore, the Wave program has garnered substantial interest from strategic partners for its rapid susceptibility testing, crucial for sepsis patients. These are the recent developments in the company's operations.
InvestingPro Insights
The FDA clearance for Accelerate Diagnostics' Arc system and BC kit comes at a critical time for the company, as reflected in recent financial data and market performance. According to InvestingPro data, Accelerate Diagnostics has a market capitalization of $41.68 million, indicating it's a small-cap company in the medical diagnostics sector.
Despite the positive news of FDA clearance, the company faces significant financial challenges. An InvestingPro Tip reveals that Accelerate Diagnostics is "quickly burning through cash," which could be a concern for investors considering the capital-intensive nature of medical technology development and commercialization. This cash burn rate is particularly noteworthy given that the company's revenue for the last twelve months as of Q2 2024 was only $12.23 million, with a modest revenue growth of 4.87% over the same period.
Another InvestingPro Tip highlights that analysts do not anticipate the company to be profitable this year. This aligns with the reported operating income margin of -360.84% for the last twelve months, suggesting substantial operational costs relative to revenue. The negative EBITDA of -$40.77 million further underscores the company's current financial struggles.
However, it's worth noting that Accelerate Diagnostics has seen a significant return over the last week, with a 15.03% price increase. This recent uptick could be attributed to investor optimism surrounding the FDA clearance announcement. Moreover, the stock has shown strong performance over the last three months, with a 50.43% price total return, indicating growing market interest in the company's potential.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Accelerate Diagnostics, providing a deeper understanding of the company's financial health and market position.
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