About Accelerate Diagnostics

Accelerate Diagnostics, Inc. operates as an in vitro diagnostics company. The company focuses on providing solutions that improve patient outcomes through the rapid diagnosis of serious infections. The company provides the Accelerate Pheno system. The Accelerate PhenoTest BC kit, which is the first test kit for the system, is indicated as an aid, in conjunction with other clinical and laboratory findings, in the diagnosis of bacteremia and fungemia, both life-threatening conditions with high morbidity and mortality risk. The device provides identification (ID) results followed by antibiotic susceptibility testing (AST) for certain pathogenic bacteria commonly associated with or causing bacteremia. This test kit utilizes genotypic technology to identify infectious pathogens and phenotypic technology to conduct AST, which determines whether live bacterial cells are resistant or susceptible to a particular antimicrobial. This information can be used by physicians to rapidly modify antibiotic therapy to lessen adverse events, improve clinical outcomes, and help preserve the useful life of antibiotics. The company declared its conformity to the European In Vitro Diagnostic Directive 98/79/EC and applied a CE mark to the Accelerate Pheno system and the Accelerate PhenoTest BC Kit for in vitro diagnostic use. The U.S. Food and Drug Administration (FDA) granted its de novo classification request to market its Accelerate Pheno system and Accelerate PhenoTest BC Kit. The company sells the Accelerate Pheno system in hospitals in the United States, Europe, and the Middle East. The company offers its second test for use on the Accelerate Pheno system, the PhenoTest BC Kit, and AST configuration. This test kit runs antibiotic susceptibility testing following the input of an ID result from another system or methodology. In March and May 2022, the company announced the launch and commercialization of the Accelerate Arc system and BC Kit (Accelerate Arc Products). This instrument and associated one-time-use test kit automates the clean-up and concentration of microbial cells from positive blood culture samples. In May 2022, the company announced IVD registration of the Accelerate Arc system and BC Kit with the FDA as a Class I device exempt from FDA clearance requirements, and in June 2022 it received CE In Vitro Diagnostic Regulation (IVDR) registration for use in Europe. In October 2022, the company announced it has been in recent discussions with the FDA regarding its Accelerate Arc Products. Pursuant to such discussions, the FDA has challenged the company's commercialization of the Accelerate Arc Products in the United States as a Class I device exempt from 510(k) clearance requirements. The company is in active dialogue with the FDA to determine the appropriate regulatory pathway. While these discussions are ongoing, it has put on hold in the United States its sales and marketing efforts of the Accelerate Arc Products. The company has continued to market the Accelerate Arc Products in Europe pursuant to its existing CE IVDR registration. Products The Accelerate Pheno system is the company's first in vitro diagnostic platform and is intended for the ID and AST of pathogens most commonly associated with serious or health care-associated infections, including Gram-positive and Gram-negative organisms. The system leverages long-accepted bacteriological testing principles enhanced by proprietary technology and automation enabling the analysis of live microbial cells. It detects and identifies pathogens directly from a single patient sample followed by antimicrobial susceptibility testing based on the ID results. Antimicrobial susceptibility is determined by morphokinetic cellular analysis (MCA), a process that evaluates the change of individual cells and microcolonies in response to a range of antibiotics over time. ID results are typically available within 90 minutes of presenting the patient sample to the system, and susceptibility results, including minimum inhibitory concentrations (MIC), are available about five hours after ID results. In the case of the Accelerate PhenoTest BC kit for positive blood culture samples, a blood culture screening step is required, which the company estimates takes an average of approximately 12 hours to complete before the sample is introduced to the Accelerate Pheno system. The Accelerate Pheno system features walk-away automation and consists of a fixed instrument and proprietary single-use test kit. The instrument consists of module(s) connected to a single analysis computer, which allows hospitals to acquire various numbers of modules to address their particular test volume. In order to run a patient sample on the Accelerate Pheno system a laboratory technician would pipette the patient sample into the company's system, insert the Accelerate PhenoTest BC kit, and initiate the run. In the case of the company's initial test, a positive blood culture sample is introduced to the system by pipetting directly from the blood culture bottle into its Accelerate PhenoTest BC kit. The Accelerate Pheno system is the result of over a decade of technological development and several years of instrument design and engineering. The system consists of custom-engineered functional components, including a robotic pipettor for fluidic manipulation, an optical system with both dark-field and fluorescent illumination, and an imaging system. These sensor components, among others, are used in the four processes that follow, each of which is a crucial component in delivering the rapid ID and AST results. These processes include: Automated Specimen Preparation: The initial step in the process is the automated purification of samples through an on-board and proprietary process to separate live organisms from sample debris. Live-Cell Immobilization: Following preparation, the purified sample is moved to the imaging cassette where pathogens are immobilized onto the cassette surface such that they can be imaged and analyzed in a stationary position during the ID and AST testing. ID Testing Via Fluorescent In Situ Hybridization (FISH): The immobilized cells are tested with the company's proprietary FISH probes to enable identification. When the probe finds a targeted sequence, it binds to it-generating a fluorescent signal-which is visible by the imaging system on the Accelerate Pheno system. Positive fluorescent signals from more than one target probe indicate polymicrobial samples and a universal bacterial stain discriminates target from non-target bacteria or fungi. The ID result is presented on the Accelerate Pheno system's graphic user interface in approximately 90 minutes from the introduction of the sample into the Accelerate Pheno system. Susceptibility Testing Via Live-Cell Optical Analysis: With the ID of the pathogen known, the system's software determines the antibiotic panel to be used for susceptibility testing. These antibiotics, growth media, and additional patient sample are introduced to additional channels on the optical cassette. Finally, the company's proprietary imaging platform and algorithms determine the minimum inhibitory concentration of the bacteria by observing, which antibiotics arrested live cell growth and led to cell death and which antibiotics were ineffective in ceasing live cell growth. The susceptibility test result is presented approximately five hours after the conclusion of the ID test. Sales, Marketing, and Distribution The target customers for the company's products are hospital microbiology laboratories that perform ID and AST. In August 2022, the company entered into the Sales and Marketing Agreement (the Sales and Marketing Agreement) with Becton, Dickinson and Company (BD) pursuant to which BD will perform certain sales, tactical marketing, technical service call forwarding, order preparation, research and development support and/or regulatory activities on its behalf as its worldwide exclusive sales agent for certain of its products, including the Accelerate Pheno and Accelerate Arc Products. An existing team of Accelerate sales and service specialists will partner with BD personnel in the United States and select international countries to market, sell, and support the Accelerate Pheno system and Accelerate Arc Products. The Sales and Marketing Agreement also grants to BD certain other rights to certain of the company's future products, including its next generation rapid AST system. BD has an exclusive right of first negotiation to be the exclusive sales agent to commercialize the company's next generation rapid AST system, which will be triggered if it proposes to license its next generation rapid AST system or sell its rights to such system, or if the company and BD mutually agree that the related clinical data is ready to be submitted to the FDA for 510(k) clearance. In accordance with the BD Agreement, the terms of such subsequent agreement would have to be negotiated by the parties. Intellectual Property The company's patented technology covers key components of the Accelerate Pheno system and applied for patents related to its next generation AST system and methods, and is, thus, critical to it. The company's patents are focused on several key technologies, including its automated process for sample preparation, and methods for imaging and analysis of individual pathogen cells. The company's first patent on the Accelerate Pheno system technology, U.S. Patent No. 7,341,841 titled Rapid Microbial Detection and Antimicrobial Susceptibility Testing, was issued on March 11, 2008. The patent specification covers methods used to derive ID and antibiotic susceptibility from tests on individual immobilized bacterial cells. As of December 31, 2022, the company had 52 issued patents worldwide, including 22 patents issued in the United States and 30 issued outside the United States. The company's patents are set to expire on various dates in 2022 through 2035. Additionally, as of December 31, 2022, the company had 5 patent applications pending worldwide, including eight U.S. applications and four applications outside the United States. From a trademark perspective, the company had 41 registered marks protecting its brand and prospective products both domestically and internationally. Government Regulation In the United States, the company's products are regulated as medical devices by the FDA and other federal, state, and local regulatory authorities. To obtain 510(k) clearance, the company must submit a pre-market notification to the FDA demonstrating that the proposed device is substantially equivalent to a device that has previously obtained 510(k) clearance, a device that has been classified into Class I or II, or a device that was legally marketed before May 28, 1976. History The company was founded in 1982. It was incorporated in Colorado in 1982. The company was formerly known as Sage Resources Corp. and changed its name to Accelerate Diagnostics, Inc. in 2012.