Rapid AST Platform Provides Targeted Therapeutic Results Days Faster Than Current Standard of Care

By LabMedica International staff writers
Posted on 08 Mar 2024

Image: The Selux PBC Separator with Selux AST System has received FDA 510(k) clearance (Photo courtesy of Selux Diagnostics)

Bacteria are outpacing scientific advancements, leading to a worrying increase in antibiotic resistance, a situation the World Health Organization has identified as an emerging global health crisis. The key to countering this trend lies in achieving quicker diagnostic results, comprehensive susceptibility testing across various sample types, and the ability to test against a broad range of commercially relevant antibiotics simultaneously. Now, a rapid antibiotic susceptibility testing (AST) system can provide targeted therapeutic results days faster than the current standard of care.

Selux Diagnostics (Boston, MA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. The addition of positive blood culture sample type expands the Selux Next Generation Phenotyping (NGP) System, making this the only FDA-cleared, single-platform technology to deliver rapid AST results for both positive blood culture and isolated colonies.

The Selux PBC Separator streamlines the process for laboratories by enabling direct testing from positive blood culture samples, eliminating the need to subculture. This automated sample preparation for susceptibility testing enhances efficiency significantly. The recent FDA clearance allows the determination of bacterial susceptibility to 17 distinct antibiotic agents included in the Selux Gram Negative Panel. Previously awarded the FDA Breakthrough Designation, the Selux PBC Separator is recognized for its potential to meet the urgent need for conducting AST directly from positive blood culture samples and other sterile body fluids.

"This third 510(k) clearance for Selux marks a significant advancement in infectious disease care,” said Steve Lufkin, CEO of Selux Diagnostics. “The Selux NGP System is the only AST platform able to deliver rapid AST results direct from positive blood culture and isolated colonies. We extend our gratitude to our employees, partners, and advisors whose contributions were instrumental in achieving this breakthrough designated accomplishment."

Related Links:
Selux Diagnostics