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Accelerate Diagnostics, Inc. (NASDAQ: AXDX) delivers innovative solutions for rapid infectious disease testing through its proprietary diagnostic platforms. This page provides investors and healthcare professionals with essential updates on company developments, financial performance, and technological advancements in antimicrobial susceptibility testing.
Access the latest press releases, earnings reports, and regulatory milestones related to AXDX's FDA-cleared systems. Our curated news collection helps stakeholders track progress in combating antibiotic resistance and improving sepsis management through accelerated diagnostics.
Key updates include product launch announcements, partnership developments, and clinical study results for platforms like the Accelerate Pheno® system. All content is verified through primary sources to ensure accuracy and relevance for investment research and clinical decision-making.
Bookmark this page for streamlined access to Accelerate Diagnostics' official communications. Check back regularly for real-time updates on innovations shaping the future of rapid in vitro diagnostics.
Accelerate Diagnostics (AXDX) has submitted its Accelerate WAVE™ system and positive blood culture gram-negative test kit to the FDA for 510(k) clearance. The WAVE system performs rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolate colonies, delivering results in approximately 4.5 hours.
The system features high throughput capacity, scalable design, and user-friendly workflow, aiming to provide microbiology laboratories with a comprehensive AST solution. This technology addresses a critical healthcare challenge, as sepsis affects 49 million people globally annually, causing 11 million deaths, with 1.32 million deaths attributed to bacterial antimicrobial resistance. In the U.S., sepsis represents a $62 billion annual healthcare cost.
Accelerate Diagnostics (NASDAQ: AXDX) has released its Q4 and full-year 2024 financial results, showing declining performance. Q4 net sales decreased to $2.8 million from $3.0 million year-over-year, with gross margin falling to 16% from 21%. The company reported a Q4 net loss of $9.6 million ($0.38 per share).
For full-year 2024, net sales declined to $11.7 million from $12.1 million, despite a 3% increase in consumable products revenue. The annual gross margin improved slightly to 23% from 21%. The company reduced both SG&A costs to $21.3 million (from $31.2 million) and R&D expenses to $16.7 million (from $25.4 million). The full-year net loss was $50.0 million ($2.15 per share).
Cash position ended at $16.3 million, down $4.6 million from the start of Q4. The company announced it will discontinue regular earnings conference calls.
Accelerate Diagnostics (AXDX) has released preliminary, unaudited results for Q4 and full-year 2024. The company reported preliminary revenue of approximately $11.7 million for the year, compared to $12.1 million in 2023. While consumable product revenues increased by 3%, overall revenue declined due to lower Pheno instrument capital sales.
The company maintained around 350 revenue-generating Pheno instruments in the U.S. and secured over 75% of U.S. Pheno customers through the anticipated WAVE commercial launch. The ongoing WAVE System and Gram-Negative Clinical Trial shows promising results, with an average time-to-result of 4.5 hours. AXDX expects FDA submission in Q1 2025 with commercial launch anticipated in late 2025.
Cash and cash equivalents stood at $16.3 million at year-end, down from $20.9 million at the start of Q4, representing a $4.5 million reduction in the quarter, showing continued reduction in operating cash use.
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.
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