Accelerate Diagnostics' Accelerate Arc System Receives FDA Clearance for Rapid Microbial Identification
Key Insights
The FDA has cleared Accelerate Diagnostics' Accelerate Arc system (search) for rapid microbial identification from positive blood cultures, aiding in sepsis (search) management.
The system automates sample preparation for Bruker's MALDI Biotyper, reducing the need for overnight cultures and accelerating result delivery.
By providing rapid identification and antibiotic susceptibility testing, the system enables clinicians to optimize antibiotic therapy sooner, improving patient outcomes.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Accelerate Arc system (search) and BC kit. This innovative, automated platform is designed for positive blood culture sample preparation and will be used with Bruker's MALDI Biotyper® CA System (MBT-CA System) and MBT-CA Sepsityper® software extension.
Streamlining Microbial Identification
The Accelerate Arc system (search) is tailored for clinical laboratories, featuring a simplified workflow that automates positive blood culture sample preparation. This automation supports direct downstream microbial identification (ID) using Bruker's MBT-CA system, eliminating the necessity for overnight culture methods. The reduction in wait time for microbial ID results is particularly critical in combating sepsis (search).
Impact on Sepsis and Antimicrobial Resistance
The Accelerate Arc system (search) leverages the extensive Bruker MBT-CA reference library to deliver rapid ID results. When used in conjunction with Accelerate Diagnostics' future Accelerate WAVE™ system, it promises same-shift reporting to Antimicrobial Stewardship teams and clinicians. According to Accelerate Diagnostics, providing clinicians with rapid ID and AST results enables them to initiate optimal antibiotic therapy sooner, which has been shown to improve patient outcomes in sepsis (search), reduce antimicrobial resistance (search) rates, and lower hospital costs.
Replacing Traditional Methods
In addition to its speed and efficiency, the Accelerate Arc system (search) is designed to replace both overnight subculture and laborious Laboratory Developed Test (LDT) sample preparation methods. With increasing regulatory pressure on LDTs, clinical laboratories can now adopt the Accelerate Arc system as an automated, FDA-cleared alternative.
Company Leadership Perspective
"The FDA Clearance of the Accelerate Arc system (search) marks the beginning of an exciting journey in our broader innovation roadmap. Together with the Accelerate WAVE™ system we are positioned to empower laboratories to deliver faster, more actionable results to clinicians, ultimately enhancing patient care and outcomes," said Jack Phillips, President and CEO of Accelerate Diagnostics.
About Accelerate Diagnostics
Accelerate Diagnostics, Inc. is focused on providing solutions for the global challenges of antibiotic resistance and sepsis (search). Their existing Accelerate Pheno system and Accelerate PhenoTest® BC kit combine technologies to reduce the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. The FDA-cleared Accelerate Pheno system and Accelerate PhenoTest BC kit fully automate sample preparation, identification, and phenotypic antibiotic susceptibility testing in approximately seven hours directly from positive blood cultures. External studies suggest that this solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.