United States

Profile: Accelerate Diagnostics Inc (AXDX.O)

AXDX.O on Consolidated Issue listed on NASDAQ Capital Market

22 May 2017
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Accelerate Diagnostics, Inc., incorporated on December 24, 2012, is an in vitro diagnostics company engaged in providing solutions that develop patient outcomes through the diagnosis of serious infections. The Company's in vitro diagnostic platform, the Accelerate Pheno system utilizes genotypic technology to identify (ID), infectious pathogens and phenotypic technology to conduct antibiotic susceptibility testing (AST), which determines whether live bacterial or fungal cells are resistant or susceptible to a particular antibiotic. It detects and identifies pathogens directly from a single patient sample followed by antimicrobial susceptibility testing based on the identification results. The Accelerate PhenoTest BC Kit provides ID and AST results for patients suspected of bacteremia or fungemia, both life-threatening conditions with high morbidity and mortality risk.

The Accelerate Pheno system features walk-away automation and consists of a fixed instrument and 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 its system, insert the Accelerate PhenoTest BC Kit, and initiate the run. In the case of its initial test a positive blood culture sample is introduced to the system through pipetting directly from the blood culture bottle into its Accelerate PhenoTest BC Kit. As of December 31, 2016, the Accelerate PhenoTest BC kit included 140 assays for both identification and susceptibility testing, of which 116 were cleared by the food and drug administration (FDA) and 24 assays were available in an research use only (RUO) mode of the software. The kit also includes monomicrobial test indicating when a patient's positive blood culture sample has only one targeted pathogen. The Accelerate Pheno 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, including Automated specimen preparation; Live-cell immobilization; Identification testing through fluorescent in situ hybridization (FISH), and Susceptibility testing via live-cell optical analysis.

The Company competes with Becton, Dickinson and Company, bioMerieux, Danaher Corporation, Bruker Corporation, Luminex Corporation, T2 Biosystems, Abbott and Thermo Fisher Scientific.

Company Address

Accelerate Diagnostics Inc

3950 S. Country Club Road #470
Building 3-307
TUCSON   AZ   85714-2240
P: +1303.8638088
F: +1302.6555049

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