Accelerate Pheno System

by Accelerate Diagnostics  · Based in United States → — Rapid Diagnostics for Bloodstream Infections and Sepsis
Critical Care Infectious Disease Laboratory Medicine

Contact vendor for pricing
Regulatory Status Disclosed

Overview

The Accelerate Pheno System is a fully automated in vitro diagnostic platform designed for rapid identification (ID) and antimicrobial susceptibility testing (AST) directly from positive blood cultures. It is NOT an AI tool for a physician directory. This system significantly reduces the time required to identify pathogens and determine their susceptibility to various antibiotics, often providing results in hours compared to the days required by conventional methods. Utilizing technologies like fluorescence in situ hybridization (FISH) for identification and morphokinetic cellular analysis (MCA) for susceptibility testing, the Accelerate Pheno System helps clinicians make targeted, life-saving therapy decisions earlier for patients with bacteremia and sepsis. This leads to improved patient outcomes, reduced length of hospital stay, and supports antimicrobial stewardship efforts by enabling optimal antibiotic selection and de-escalation.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Rapid Pathogen Identification (ID) in ~90 minutes to 2 hours
  • Rapid Antimicrobial Susceptibility Testing (AST) in ~5 to 7 hours
  • Directly from positive blood cultures
  • Fully automated workflow with minimal hands-on time
  • Utilizes Fluorescence In Situ Hybridization (FISH) for ID
  • Employs Morphokinetic Cellular Analysis (MCA) for AST
  • Provides Minimum Inhibitory Concentration (MIC) results
  • Supports targeted antibiotic therapy and de-escalation
  • Reduces time to optimal therapy by up to 26.4 hours and length of stay by up to 2.2 days
  • Expert rule system for susceptibility interpretation based on FDA/CLSI/EUCAST breakpoints

Use Cases

  • Rapid diagnosis of bloodstream infections
  • Guiding antibiotic therapy for sepsis patients
  • Enhancing antimicrobial stewardship programs
  • Reducing hospital length of stay for patients with infections
  • Optimizing antibiotic selection and dosage
  • Detecting antibiotic resistance faster

What Physicians Need to Know

LIS/LIMS Integration
Offers bidirectional LIS connectivity for automated resulting and data transfer. Supports automated LIS alerts (text/email) to deliver actionable results to stewardship teams or providers.
Supported Assay Types
Performs identification (ID) and antimicrobial susceptibility testing (AST) directly from positive blood cultures using the Accelerate PhenoTest BC kit. Identifies a panel of Gram-positive and Gram-negative bacteria and yeasts (e.g., Staphylococcus aureus, E. coli, Klebsiella spp., Candida spp.) and tests a broad range of antimicrobial agents, including reporting resistance phenotypes like Methicillin-resistance and MLSb.
QC/QA Features
Automates external QC testing for ID and AST, eliminating manual inoculum preparation and reducing complexity. Utilizes complementary sequences coupled to polymer microspheres for enhanced analyte stability. Provides detailed QC reports with pass/fail status, identification results, and MICs.
Result Interpretation AI
Leverages morphokinetic cellular analysis by recording and comparing pathogen growth patterns using computer algorithms. Onboard software algorithms derive Minimum Inhibitory Concentration (MIC) values and apply expert rules for categorical interpretations (Susceptible, Intermediate, Resistant) based on FDA/CLSI breakpoints, providing a scoring scale for treatment options.
Critical Value Alerts
Supports automated LIS alerts (via text or email) to promptly notify stewardship teams or providers of critical results, enabling timely clinical intervention.
Instrument Interfaces
A fully integrated system with one to eight ID/AST modules, a computing system, and a touchscreen monitor. Features an intuitive user interface and secure network UI access.
Reference Range Intelligence
Interprets MIC evaluation results based on established guidelines from the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and Clinical and Laboratory Standards Institute (CLSI), incorporating breakpoints and expert rules.
Turnaround Time Impact
Significantly reduces time to identification (approx. 90 minutes) and AST results (approx. 7 hours) directly from positive blood cultures. This can reduce time to optimal therapy by up to 26.4 hours and length of hospital stay by up to 2.2 days, while also decreasing hands-on time by 25.5 to 30 minutes per culture.
Microbiology ID Support
Utilizes automated fluorescence in situ hybridization (FISH) technology with 16 probe cocktails for rapid genomic identification at species or genus level, including a 'monomicrobial call' feature. Offers flexibility with ID/AST or AST-only configurations and automatic/manual ID entry options.
Physician Tip

The Accelerate Pheno System provides rapid, actionable insights into bloodstream infections, delivering pathogen identification in ~90 minutes and full antimicrobial susceptibility results in ~7 hours. This speed is critical for optimizing antimicrobial therapy days faster than conventional methods, potentially reducing patient mortality, length of hospital stay, and the use of broad-spectrum antibiotics. The detailed MICs and AI-assisted interpretation, guided by CLSI/EUCAST breakpoints and expert rules, empower clinicians to make precise, patient-specific treatment decisions, especially for critically ill patients with sepsis.

The system is designed for seamless integration into laboratory workflows with bidirectional LIS connectivity, enabling automated result reporting and critical value alerts. Comprehensive support, including IT and clinical specialists, is provided for implementation, training, data analysis, and ongoing service, ensuring the system is tailored to the institution's unique needs.

Details

Category Lab & Diagnostics, Triage & ER/ICU AI
Pricing Contact vendor for pricing
  • Pricing for the Accelerate Pheno System and its associated kits (e.g., Accelerate PhenoTest BC Kit) is not publicly disclosed and typically involves direct consultation with Accelerate Diagnostics or its distributors
  • Used systems may be found for prices ranging from $30 to $14,500, but these are not new system prices
DeploymentOn-premise (laboratory instrument)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Accelerate Pheno System received FDA clearance in 2017. The Accelerate PhenoTest BC Kit, used with the system, received FDA 510(k) clearance (K192665) on September 15, 2020. It is cleared for rapid identification of common bloodstream pathogens and phenotypic antimicrobial susceptibility testing directly from positive blood cultures.

Integrations
EHR Not specified
Specialties Critical Care, Infectious Disease, Laboratory Medicine

What the Web Says

The Accelerate Pheno System is a fully automated diagnostic device that rapidly identifies bacteria and yeasts and performs antimicrobial susceptibility testing (AST) directly from positive blood cultures. It significantly reduces the time to identification and AST results compared to traditional methods, which can take days. This speed allows physicians to optimize antibiotic therapy sooner, potentially leading to improved patient outcomes, reduced hospital stays, and better antibiotic stewardship.

Overall: Positive

Strengths

  • Rapid identification of pathogens (around 1.4 hours)
  • Fast antimicrobial susceptibility testing (around 6.6 hours)
  • Significantly reduces time to effective antimicrobial therapy
  • Improves antibiotic stewardship by enabling targeted treatment
  • Potential for reduced length of hospital stay and patient costs
  • High sensitivity and specificity for organism identification and AST

Limitations

  • May not identify all organisms in polymicrobial infections
  • Requires a hospital antimicrobial stewardship program and 24/7 lab operation for optimal impact
  • Some studies noted minor, major, and very major errors in AST results, though overall agreement is high
  • Limited usefulness for distinguishing certain Gram-positive bacteria like Staphylococcus aureus from S. epidermidis in some cases
  • Inclusion of non-blood specimens with high likelihood of polymicrobial infections may result in inferior performance
  • Some discordant results highlighted, such as failure to identify certain organisms or suboptimal performance for specific antibiotics

Based on reviews from: Evaluation of the Accelerate Pheno System: Results from Two Academic Medical Centers, Accelerate Pheno System Speeds Up Antibiotic Susceptibility Diagnostics | HCPLive, Effective implementation of the Accelerate Phenou2122 system for positive blood cultures | Journal of Antimicrobial Chemotherapy | Oxford Academic, The Accelerate Phenou2122 system in clinical practice: fast and accurate turnaround for critical results - HealthManagement.org, Evaluation of the Accelerate Pheno System: Results from Two Academic Medical Centers - PMC, Impact on time to active antimicrobial therapy with 24-hour pharmacist review of Accelerate Pheno BC Kit results - PMC, Accelerate Phenou2122 blood culture detection system: a literature review - PubMed, Evaluation of the Accelerate Pheno System for Fast Identification and Antimicrobial Susceptibility Testing from Positive Blood Cultures in Bloodstream Infections Caused by Gram-Negative Pathogens - ASM Journals, Emerging technologies for rapid phenotypic antimicrobial susceptibility testing of clinical isolates of bacteria - PMC, Accelerate Diagnostics, Inc. - Combatting A Crisis - YouTube, Accelerate Phenou2122 Blood Culture Detection System: A Literature Review - Taylor & Francis, The Accelerate Phenou2122 Systemu2014A New Tool in Microbiological Diagnostics of Bloodstream Infections: A Pilot Study from Poland - MDPI, Accelerate Pheno: Rapid Bacterial ID - YouTube, Evaluation of the Accelerate Pheno System for Fast Identification and Antimicrobial Susceptibility Testing from Positive Blood Cultures in Bloodstream Infections Caused by Gram-Negative Pathogens - PubMed, Evaluation of the Accelerate Pheno System for Rapid Identification and Antimicrobial Susceptibility Testing of Positive Blood Culture Bottles Inoculated with Primary Sterile Specimens from Patients with Suspected Severe Infections - PMC

Last updated: 2026-07-17

Ratings & Reviews

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Press & Coverage

PR Newswire
Accelerate Diagnostics Files for Chapter 11 Protection and Agrees to Terms to Sell Substantially All Assets
Accelerate Diagnostics announced it has voluntarily initiated Chapter 11 restructuring proceedings to sell its assets through a court-supervised process. The company has secured debtor-in-possession financing to continue operations during this period.
2025-05
ElevenFlo
Accelerate Diagnostics: 97-Day Credit Bid Sale Case
Accelerate Diagnostics filed for Chapter 11 bankruptcy in May 2025, with a $718.9 million deficit, and its assets were subsequently acquired by Bruker Corporation after a credit bid by Indaba Capital Management. The Accelerate Pheno system, despite its technological validation, did not lead to profitable operations for the company.
2026-03
BioSpace
Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance
Accelerate Diagnostics submitted its Accelerate WAVEu2122 system and a gram-negative test kit to the FDA for 510(k) clearance. The Accelerate Pheno system and PhenoTestu00ae BC kit are designed to provide rapid antimicrobial susceptibility testing results in about seven hours, significantly faster than existing methods.
2025-03
PR Newswire
Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arcu2122 System
Accelerate Diagnostics received FDA 510(k) clearance for its Accelerate Arcu2122 system and BC kit, an automated platform for positive blood culture sample preparation. This system is intended for use with Bruker's MALDI Biotyperu00ae CA System to provide rapid microbial identification.
2024-09
PR Newswire
Accelerate Diagnostics Announces a Successful Completion of its WAVEu2122 Pre-Clinical Trial
Accelerate Diagnostics successfully completed its WAVE pre-clinical trial for the Accelerate WAVE system, which aims to deliver rapid antimicrobial susceptibility testing (AST) results within 4.5 hours. The Accelerate Phenou00ae system is also highlighted for its ability to provide phenotypic AST results in approximately 7 hours.
2024-08
PR Newswire
Accelerate Diagnostics Announces Certain Preliminary Fourth Quarter and Full-Year 2024 Results
Accelerate Diagnostics reported preliminary Q4 and full-year 2024 results, noting continued contract extensions with Pheno customers and the 510(k) clearance of the Accelerate Arc system. The Accelerate Pheno system provides automated identification and phenotypic AST in about seven hours.
2025-01
Q-linea
Q-linea AB (publ) (OMX: QLINEA) today announces it will provide ASTaru00ae to Italian users of the Accelerate Pheno rapid AST system
Q-linea announced it will provide its ASTaru00ae rapid AST system to Italian users of the Accelerate Pheno system, offering a replacement for rapid AST needs due to its broad coverage and high-throughput capabilities.
2025-12
MarketScreener
Accelerate Diagnostics, Inc. Went Out of Business
Accelerate Diagnostics, Inc. ceased operations as its plan of liquidation became effective on August 20, 2025.
2025-08

Videos

Product demos, reviews, and walkthroughs for Accelerate Pheno System.

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Frequently Asked Questions

The Accelerate Pheno System employs computer algorithms, a form of AI, to rapidly analyze bacterial growth patterns and identify pathogens directly from positive blood cultures. This enables physicians to receive identification in about 90 minutes and phenotypic antimicrobial susceptibility results in approximately 7 hours, significantly reducing the time to optimal antibiotic therapy for conditions like sepsis.
The Accelerate Pheno System and its associated kits, such as the Accelerate PhenoTest BC kit, are FDA-cleared for clinical use, having received initial approval in 2017. It also complies with international electrical safety and electromagnetic compatibility standards, ensuring its reliability and safety in medical laboratory environments.
The Accelerate Pheno System provides both rapid identification and phenotypic AST directly from positive blood cultures, offering results days faster than conventional culture-based methods. Unlike some molecular diagnostics that only provide limited susceptibility data, Pheno delivers comprehensive Minimum Inhibitory Concentration (MIC) values, which are crucial for precise antibiotic stewardship.
Key limitations include its capacity to process only one sample per module at a time, making it less suitable for very high-volume batch processing, and the requirement to process samples within 8 hours of blood culture positivity. Additionally, while highly accurate for many common pathogens, its performance for certain less common organisms or specific antibiotic combinations may have limitations.
While specific new system pricing is not readily available, the Accelerate Pheno System's rapid results can lead to significant cost savings by reducing the time patients spend on expensive broad-spectrum antibiotics and potentially shortening hospital stays. This improved antibiotic stewardship and faster targeted therapy can offset initial investment costs through better patient outcomes and resource utilization.
The system's AI primarily automates and accelerates the diagnostic process by analyzing growth patterns, providing objective data (ID and AST results) to the physician. Physicians retain full responsibility for clinical decision-making, using the rapid results as a critical tool to inform and optimize patient-specific antibiotic therapy, rather than replacing their judgment.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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