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Accelerate Diagnostics, Inc. (NASDAQ: AXDX) is a prominent in vitro diagnostics company that focuses on developing and commercializing innovative systems for the rapid identification and antimicrobial susceptibility testing (AST) of infectious pathogens. The company’s cutting-edge platform, the Accelerate ID/AST System, utilizes a proprietary process combining genomic and phenotypic detection technologies, significantly reducing the time to results while maintaining high sensitivity and specificity.
One of Accelerate Diagnostics' key products is the Accelerate Pheno® system and the accompanying PhenoTest® BC kit, which automate the sample preparation steps and provide phenotypic antibiotic susceptibility results directly from positive blood cultures in approximately seven hours. This is 1–2 days faster than traditional methods, allowing clinicians to optimize antibiotic selection and dosage for individual patients much sooner.
The company has also developed the Arc™ system, an automated positive blood culture sample preparation platform that collaborates with Bruker Corporation's MALDI Biotyper® sirius instruments, streamlining microbial identification without overnight culture incubation. This system is currently undergoing validation for registration in the US and EMEA markets.
In addition to its diagnostic systems, Accelerate Diagnostics owns and licenses its proprietary OptiChem™ surface coatings technology, which has diverse applications in bio-analytical systems such as microarrays.
Financially, the majority of Accelerate Diagnostics’ revenue comes from the domestic market. The company has been investing heavily in the development of its next-generation rapid AST system, Accelerate Wave™, and has planned clinical trials for this innovative system for mid-2024. Recent financial announcements indicate the company has been successful in forming strategic partnerships, expanding its customer base, and securing long-term contracts.
With an unwavering commitment to addressing global challenges like antibiotic resistance and sepsis, Accelerate Diagnostics continues to lead the market with rapid, reliable, and cost-effective diagnostic solutions, ensuring better patient outcomes and reducing healthcare costs.
Accelerate Diagnostics (Nasdaq: AXDX) reported its Q3 2024 financial results, showing net sales of $3.0 million, a decrease from $3.3 million in Q3 2023. The decline was attributed to lower instrument sales, partially offset by a 9% increase in consumable products. Gross margin improved to 29%, up from 3% last year, due to a favorable product mix and prior year inventory write-downs. SG&A expenses dropped to $5.6 million from $7.8 million, and R&D costs fell to $3.8 million from $7.0 million, driven by reduced employee-related and third-party development costs. The company reported a net loss of $14.6 million, or $0.59 per share, and ended the quarter with $20.9 million in cash and equivalents, up from $9.7 million, boosted by a $15 million debt issuance. Key operational highlights include the launch of the WAVE system and Gram-Negative assay clinical trial, FDA clearance for the Accelerate Arc system, and the addition of five new Pheno instruments, bringing the total to 352 revenue-generating instruments.
Accelerate Diagnostics (NASDAQ: AXDX) has announced a conference call scheduled for Thursday, November 7, 2024, at 4:30 p.m. Eastern Time to review their 2024 third quarter results. The call will be accessible via audio webcast at ir.axdx.com, with a replay available for 30 days. Participants can join by phone at +1.877.883.0383 (US) or +1.412.902.6506 (International) using Elite Entry Number 1269422. A telephone replay will be available until November 28, 2024.
Accelerate Diagnostics (NASDAQ: AXDX) has received FDA 510(k) clearance for its Accelerate Arc system and BC kit, an automated platform for rapid microbial identification from positive blood culture samples. The system is designed to work with Bruker's MALDI Biotyper® CA System and MBT-CA Sepsityper® software extension, eliminating the need for overnight culture methods and reducing wait times for results.
The Accelerate Arc system aims to provide rapid identification leveraging Bruker's MBT-CA reference library. When combined with the future Accelerate WAVE™ system for rapid antibiotic susceptibility testing, it could enable same-shift reporting to Antimicrobial Stewardship teams and clinicians. This innovation is expected to improve patient outcomes in sepsis cases, reduce antimicrobial resistance rates, and lower hospital costs by enabling faster, optimal antibiotic therapy.
Accelerate Diagnostics (Nasdaq: AXDX) announced its Q2 2024 financial results, reporting net sales of $3.0 million, up from $2.9 million YoY. Consumable product revenues increased by 12%. Gross margin declined to 23% from 27% due to a lower capital instrument sales mix. SG&A expenses fell to $5.4 million from $7.6 million, driven by reduced employee-related costs. R&D expenses decreased to $3.9 million from $5.8 million, owing to lower third-party development costs. Net loss was $11.6 million, with a net loss per share of $0.50. Cash and cash equivalents stood at $9.7 million.
Key operational highlights include a successful pre-clinical trial for the WAVE system, securing $15 million in additional funding, and retaining Perella Weinberg Partners for strategic review. The company added 5 new contracted Pheno instruments, totaling 350 live instruments. Full financial results are available on the SEC website.
Accelerate Diagnostics (NASDAQ: AXDX) has successfully completed its WAVE pre-clinical trial for rapid antimicrobial susceptibility testing (AST). The WAVE system delivers AST results from positive blood cultures and bacterial isolates in an average of 4.5 hours. The trial included 1,570 WAVE results compared to Broth Microdilution, showing overall Essential Agreement (EA) and Categorical Agreement (CA) of approximately 95%.
The system aims to improve patient outcomes, reduce hospital costs, and combat antimicrobial resistance in sepsis treatment. Sepsis affects an estimated 49 million people globally each year, causing about 11 million deaths, with 1.32 million attributed to bacterial antimicrobial resistance. It's also the leading cost to the US healthcare system at an estimated $62 billion annually.
Accelerate Diagnostics (NASDAQ: AXDX) has announced a conference call scheduled for Thursday, August 8, 2024, at 4:30 p.m. Eastern Time to review the company's 2024 second quarter results. Investors and interested parties can access the audio webcast online at ir.axdx.com, with a replay available for 30 days. For those preferring to listen by phone, dial-in options are provided for both U.S. and international participants. A telephone replay will be accessible until August 29, 2024, using specific replay codes for U.S. and international callers.
Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported preliminary financial results for the first quarter of 2024, highlighting the installation of their pre-clinical trial site and progress in developing the Accelerate Wave™ system. The company secured contract extensions with strategic customers and added new Pheno instruments in the US. Despite a slight increase in sales, there was a decline in gross margin due to product sales mix. Operating costs reduced significantly, leading to a net loss of $17.0 million for the quarter.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) will host a conference call on May 8, 2024, at 4:30 p.m. ET to review the 2024 first quarter results. The call can be accessed online or by phone, with a replay available for 30 days. International participants can also join the call.
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