The US Food and Drug Administration (FDA) has granted 510(k) clearance to Accelerate Diagnostics’ Accelerate Arc system and BC kit, which is designed for the rapid identification of microbial infections.

This automated positive blood culture sample preparation platform is designed for clinical laboratories to expedite the process of microbial identification (ID), which is crucial in the treatment of sepsis.

The Accelerate Arc system simplifies the workflow by automating the sample preparation for direct downstream microbial ID using Bruker's MALDI Biotyper CA System (MBT-CA System) and MBT-CA Sepsityper software extension.

It helps avoid the need for traditional overnight culture methods, allowing for quicker microbial ID results.

The system utilises the Bruker MBT-CA reference library, aiming to provide rapid ID results.

The prompt ID and AST results can significantly improve patient outcomes, particularly in sepsis cases, and reduce both antimicrobial resistance rates and hospital costs.

Accelerate Diagnostics president and CEO Jack Phillips said: “The FDA clearance of the Accelerate Arc system 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.”

The Accelerate Arc system also aims to replace overnight subculture and time-consuming laboratory-developed test (LDT) sample preparation methods.

With increasing legislation and enforcement regarding the use of LDTs, clinical laboratories now have the option to adopt the Accelerate Arc system as an automated, FDA-cleared alternative.

The Accelerate WAVE system is undergoing clinical trials as part of the process for submitting a 510(k) application to the FDA. The system aims to deliver average results within 4.5 hours.

In November 2023, Accelerate Diagnostics and Bruker signed a collaboration and quality agreement to validate the use of the Arc system with the MALDI Biotyper system.