Accelerate Diagnostics, Inc. AXDX recently announced the completion of the pre-clinical trial of its WAVE system. The WAVE pre-clinical trial showed strong performance, along with strong instrument reliability and assay reportability.
With the latest success, the company is confident about WAVE product design and the system's capabilities. This, in turn, should help Accelerate Diagnostics to move ahead with a clinical trial and further commercialize the WAVE system.
About the WAVE System
The 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. The system, which will offer a comprehensive test menu, is incorporated with essential features to optimize workflow across laboratories.
Significance of the Pre-Clinical Trial
World Health Organization estimated that Sepsis affects an estimated 49 million people globally each year, causing an estimated 11 million deaths, of which almost 1.3 million can be attributed to bacterial antimicrobial resistance. Additionally, Sepsis is the number one contributor to the U.S. healthcare system’s annual expenses, reaching approximately $62 billion.
With the help of Accelerate Diagnostics’ WAVE system's 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.
More on the News
The pre-clinical trial included 1,570 WAVE results compared with Broth Microdilution ("BMD"), the reference method. The trial included an equal number of prospective patient samples and site-selected challenge samples, which showed excellent concordance between sample types. Summary of the performance showed overall Essential Agreement ("EA") and Categorical Agreement ("CA") of approximately 95%.
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Market Prospects
Per a report from Skyquest, the global Antimicrobial Susceptibility Testing market size was valued at $3.79 billion in 2023 and is poised to reach $5.69 billion by 2031, at a CAGR of 5.2%. The primary factor influencing the market growth is the escalating burden of antimicrobial resistance, resulting in increased morbidity, mortality and healthcare costs. The rise in infectious disease outbreaks, hospital-acquired infections and the growing awareness about the need for targeted therapies also drive market growth.
Accelerate Diagnostics’ recent development for its WAVE system is well-timed and in favour of the market growth.
Other Recent Developments
In April 2024, Accelerate Diagnostics announced 510(k) submission to the FDA for its Accelerate Arc system and BC kit — an innovative, automated positive blood culture sample preparation platform for use with Bruker’s MALDI Biotyper CA (MBT-CA) System and MBT-CA Sepsityper software extension.
Price Performance
Year to date, shares of AXDX have lost 55.3% against the industry’s 4.7 % growth.
Zacks Rank and Other Key Picks
Accelerate Diagnostics currently carries a Zacks Rank #2 (Buy).
Other other top-ranked stocks in the broader medical space are Intuitive Surgical ISRG, TransMedics Group TMDX and Quest Diagnostics DGX. While Intuitive Surgical and TransMedics sport a Zacks Rank #1 (Strong Buy) each, Quest Diagnostics carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Intuitive Surgical’s shares have surged 53% in the past year. Estimates for the company’s earnings have moved north 5.1% to $1.65 per share for 2024 in the past 30 days.
ISRG’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 8.97%. In the last reported quarter, it posted an earnings surprise of 16.34%.
Estimates for TransMedics’ 2024 EPS have moved up 83.3% to 22 cents in the past 30 days. Shares of the company have soared 157.1% in the past year compared with the industry’s 7.2% growth.
TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.
Estimates for Quest Diagnostics’ 2024 EPS have decreased 0.4% to $2.28 in the past 30 days. In the past year, shares of HAE have risen 13% compared with the industry’s 18.4% growth.
In the last reported quarter, DGX delivered an earnings surprise of 1.73%. The company has a trailing four-quarter average earnings surprise of 3.31%.
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