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TUCSON, Ariz. – Accelerate Diagnostics, Inc. (NASDAQ:AXDX), a company specializing in rapid in vitro diagnostics with a current market capitalization of $28 million, has announced the submission of its Accelerate WAVE™ system and associated test kit for gram-negative bacteria in positive blood cultures to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. According to InvestingPro data, the company faces significant financial challenges while pursuing regulatory approval, with a negative EBITDA of $34.67 million in the last twelve months.
The submission, made today, marks a significant step for the company in bringing to market a system that promises to deliver rapid antimicrobial susceptibility testing (AST) results. The WAVE system is designed to provide accurate AST directly from positive blood culture bottles and bacterial isolate colonies within an average of 4.5 hours. This rapid turnaround is intended to enable healthcare providers to administer targeted antimicrobial therapy more quickly for patients with serious infections. Despite operating with a significant debt burden of nearly $59 million, the company maintains a current ratio of 1.5, suggesting adequate short-term liquidity to support its operations.
The World Health Organization reports that sepsis affects an estimated 49 million people globally each year, leading to about 11 million deaths. A portion of these deaths, approximately 1.32 million, are attributed to bacterial antimicrobial resistance. In the United States, sepsis represents a significant cost burden on the healthcare system, with an estimated annual expense of $62 billion.
Accelerate Diagnostics asserts that the WAVE system can improve patient outcomes by supporting earlier, targeted antimicrobial therapy, which may also reduce hospital costs and help combat antimicrobial resistance.
Currently, Accelerate Diagnostics offers FDA-cleared platforms such as the Accelerate Pheno system and Accelerate PhenoTest® BC kit, along with the Accelerate Arc™ system and BC kit. These products aim to reduce the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. With annual revenue of $11.91 million and a gross profit margin of 24.25%, the company’s commercialization efforts continue despite challenging market conditions. InvestingPro analysis indicates the stock is currently undervalued, with additional insights available through their comprehensive Pro Research Report, which covers over 1,400 US equities.
The company’s latest submission for the WAVE system, if approved, would expand its portfolio of rapid diagnostic solutions, providing microbiology laboratories with a high-throughput and scalable option for meeting diverse testing demands.
This announcement is based on a press release statement and has not been independently verified. The effectiveness and commercial availability of the WAVE system are contingent on FDA clearance, and the company’s forward-looking statements are subject to risks and uncertainties, including regulatory approval processes and the company’s financial condition.
In other recent news, Accelerate Diagnostics has been notified by the Nasdaq Stock Market about a potential delisting risk due to its market value falling below the required minimum. The company disclosed that it received a notice from Nasdaq indicating that its market value had been below the $35 million threshold for the last 30 consecutive business days. Accelerate Diagnostics has been given until July 28, 2025, to regain compliance with Nasdaq’s Market Value of Listed Securities requirement. To meet this requirement, the market value of its common stock must close at $35 million or more for at least ten consecutive business days before the compliance deadline. While the notice does not immediately affect the listing of its common stock, failure to meet the requirement by the deadline could lead to delisting. The company would then have the opportunity to appeal the decision before a Nasdaq Hearing Panel. Accelerate Diagnostics is currently assessing potential courses of action to regain compliance and is actively monitoring its market value. However, the company has stated that there is no guarantee it will achieve compliance within the given timeframe.
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