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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, Inc. (NASDAQ: AXDX) presented new data on the Accelerate Arc Module and BC kit at ECCMID 2022 in Lisbon. The studies revealed that the Arc System enables rapid and accurate microbial identification from positive blood cultures, achieving 94% or greater accuracy compared to conventional MALDI methods. Notably, one study reported 100% agreement in sample results between the Arc and traditional methods. The Arc can identify microorganisms in 90% of blood cultures with minimal hands-on time, significantly improving workflow efficiency for clinical labs.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) launched the Accelerate Arc System on March 28, 2022. This system, designed for labs using MALDI, automates microbial identification from positive blood cultures, significantly reducing wait times and manual processes. The Arc Module integrates inline centrifugal techniques for rapid microbial ID results with just 2-3 minutes of technician hands-on time. This innovation can lower costs by up to 50% compared to existing molecular ID solutions and aims to mitigate contamination issues observed with multi-targeted molecular tests.
Accelerate Diagnostics (AXDX) reported a net sales increase of 6%, reaching $3.3 million in Q4 2021 and a total of $11.8 million for the year, up 5% year-over-year. Despite this growth, the company's net loss widened to $22.8 million in Q4, attributed to non-cash expenses. Gross margin fell to 35% due to pandemic impacts. The company added 16 contracted instruments in Q4, bringing the total to 313 live revenue-generating devices in the U.S. R&D costs decreased slightly to $4.6 million, while total cash and equivalents stood at $63.6 million by year-end.
Accelerate Diagnostics (NASDAQ: AXDX) announced a conference call scheduled for March 8, 2022, at 4:30 p.m. ET to discuss its 2021 fourth quarter and full year financial results. Investors can listen to the call via audio webcast or by phone, with a replay available until March 29, 2022. The company focuses on in vitro diagnostics, providing solutions to tackle antibiotic resistance and sepsis with its FDA-cleared Accelerate Pheno® system, which delivers faster antibiotic susceptibility results.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) will present virtually at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 16, 2022, at 10:00 a.m. ET. The conference is exclusive to BTIG clients. Accelerate Diagnostics focuses on in vitro diagnostics, addressing antibiotic resistance and sepsis challenges. Their FDA-cleared Accelerate Pheno® system provides rapid phenotypic antibiotic susceptibility results in approximately 7 hours, enabling timely and optimal antibiotic therapy for patients, significantly faster than traditional methods.
Accelerate Diagnostics (NASDAQ: AXDX) reported preliminary financial results for Q4 and full-year 2021. Key highlights include Q4 expected revenue of $3.3 million, a slight increase from $3.1 million in Q4 2020. Total revenue for 2021 is projected at $11.8 million, compared to $11.2 million in 2020. The company contracted 16 new U.S. Pheno instruments in Q4, totaling 81 instruments in backlog. Gross margin for 2021 is anticipated to be around 35%. Notably, net cash used reached approximately $47 million, leaving a cash balance of $64 million.
Accelerate Diagnostics, Inc. (Nasdaq: AXDX) will present at the 40th Annual J. P. Morgan Healthcare Conference on January 13, 2022, at 9:45 a.m. Eastern Time. A live webcast of the presentation will be available online. The company specializes in in vitro diagnostics, focusing on antibiotic resistance and sepsis. Its Accelerate Pheno® system reports antibiotic susceptibility results in about 7 hours, significantly faster than traditional methods. This advancement supports clinicians in optimizing patient-specific antibiotic therapy.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) published a multi-center study in Clinical Infectious Diseases, highlighting the impact of the Accelerate Pheno system on treating bloodstream infections. The study found a 17.2-hour reduction in optimal antimicrobial therapy time and a 1-day decrease in hospital stays for Gram-negative infections. Significant improvements in mortality rates and antimicrobial management were also reported. CEO Jack Phillips emphasized the system's value in healthcare, which aligns with over 70 previous studies demonstrating its efficacy.
Accelerate Diagnostics (AXDX) reported preliminary Q3 2021 results, showing a net sales decline to $3.1 million, down 13% from Q3 2020. Despite a challenging COVID environment impacting commercial execution, the company gained three contracted instruments, ending with 304 revenue-generating instruments. Gross margin decreased to 32% due to inflation in manufacturing costs. Year-to-date net sales rose to $8.4 million, a 5% increase. However, net loss year-to-date was $54.9 million, or $0.91 per share. Total cash reserves stood at $57 million, reduced outstanding debt by 30% during the quarter.
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