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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) reported a net sales of $3.1 million for Q4 2020, reflecting a 10% decline year-over-year, while full-year sales grew by 20% to $11.2 million. The net loss for Q4 was $18.9 million, resulting in a loss of $0.33 per share. The gross margin for Q4 was 37% compared to 44% in the same quarter of 2019. Despite pandemic-related challenges impacting new instrument placements, the company saw a 63% increase in revenue-generating installed base for 2020. Total cash and equivalents stood at $68.3 million at year-end.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) has scheduled a conference call for February 23, 2021, at 4:30 p.m. Eastern Time, to discuss the financial results for the fourth quarter and full year 2020. The call will provide insights into the company’s performance, focusing on their in vitro diagnostics solutions aimed at combating antibiotic resistance and sepsis. An audio webcast will be available at ir.axdx.com, and a replay will be accessible until May 24, 2021.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) will present virtually at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 18, 2020, at 4:00 p.m. Eastern Time. A live audiocast will be available on the company’s investor relations website, with a replay provided for at least 30 days post-conference.
The company focuses on combating antibiotic resistance and sepsis through its Accelerate Pheno® system and Accelerate PhenoTest® BC kit, delivering phenotypic antibiotic susceptibility results in approximately 7 hours.
Accelerate Diagnostics (NASDAQ: AXDX) reported preliminary financial results for Q4 and full year 2020, highlighting a total revenue of approximately $3.1 million for Q4, down from $3.5 million year-over-year, but up to $11.2 million for the full year compared to $9.3 million in 2019. The company placed 45 new instruments in Q4, raising the total to 268 in the U.S., with a backlog of 133 instruments. Gross margin for 2020 is expected at 40%, with net cash used around $41 million, leaving a cash balance of $100 million post-financing. Management remains optimistic about 2021 sales and product launches.
Accelerate Diagnostics (AXDX) reported third-quarter 2020 revenues of $3.6 million, a 57% increase from the previous year. The company ended the quarter with 223 live revenue-generating Pheno instruments in the U.S. However, gross margin fell to 36% due to pandemic-related manufacturing impacts. Year-to-date net sales reached $8.1 million, a 40% rise compared to 2019. The net loss for the quarter was $18.8 million, or $0.33 per share. Cash and equivalents stood at $77.5 million. The company received FDA approvals for key product enhancements, which are expected to stimulate customer interest.
Accelerate Diagnostics, Inc. will host a virtual Investor Product Demo Day on October 20, 2020, at 11:00 a.m. Eastern Time. This event offers insights into the Company's product strategy and features live demonstrations and a Q&A with CEO Jack Phillips. Pre-registration is required by October 19, 2020. Additionally, a conference call reviewing the third quarter financial results is scheduled for November 5, 2020, at 4:30 p.m. Eastern Time.
Accelerate Diagnostics (NASDAQ:AXDX) has received FDA clearance for enhancements to its Accelerate Pheno® system. This upgrade improves antimicrobial susceptibility testing (AST) performance, particularly for treating Pseudomonas aeruginosa infections. The new tests expand the system's AST menu, aiding clinicians in personalized patient care. CEO Jack Phillips emphasized the company's commitment to continual improvement and announced upcoming product releases, including the Accelerate PhenoAST BC GN kit. These advancements aim to reduce testing time significantly, improving patient outcomes.
Accelerate Diagnostics (NASDAQ:AXDX) and BioCheck, Inc. announced FDA Emergency Use Authorization for their individual SARS-CoV-2 IgM and IgG Test Kits. This follows the EUA approval of their fully automated MS-Fast instrument. Accelerate will market and support this serology platform, which processes human serum samples in 30 minutes to detect antibodies indicating COVID-19 infection. The tests target the S1 protein to minimize false positives. The CEO emphasized the importance of flexible testing solutions as serology testing plays a crucial role in combating COVID-19.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) appointed Dr. Nedal Safwat as Chief Strategy Officer, effective immediately. Dr. Safwat, who previously held key roles at BioMerieux, is anticipated to lead the new product strategy and long-term growth initiatives. CEO Jack Phillips expressed confidence in Dr. Safwat's expertise in microbiology diagnostics. Accelerate Diagnostics focuses on combatting antibiotic resistance and sepsis, with its FDA-cleared Accelerate Pheno® system enhancing clinical outcomes by improving antibiotic therapy decisions.
Accelerate Diagnostics has received Emergency Use Authorization (EUA) from the FDA for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and the MS-Fast instrument. This collaboration enables Accelerate Diagnostics to market a serology-based platform that processes human serum samples in just 30 minutes. The test targets the S1 protein of the coronavirus, minimizing false positives. Leadership emphasizes its importance for COVID-19 demographic surveillance and potential global use. This marks a significant step toward wider adoption of antibody testing.
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