The Selux PBC Separator With Selux AST System Receives FDA 510(k) Clearance for Rapid Antibiotic Susceptibility Testing Direct From Positive Blood Culture
BOSTON, February 26, 2024 (Newswire.com) - Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and preserve the lifesaving power of antibiotics for future generations, announced it 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 NGP System, a rapid AST platform that can provide targeted therapeutic results days faster than the current standard of care.
The Selux PBC Separator allows labs to test directly from positive blood culture without the need to subculture by automatically preparing the sample for susceptibility testing. This latest FDA clearance determines a bacteria's susceptibility to 17 specific antibiotic agents on the Selux Gram Negative Panel.
The Selux PBC Separator has already garnered FDA Breakthrough Designation, acknowledging its potential to address the critical need for performing AST directly from positive blood culture and other sterile body fluids. The FDA's Breakthrough Devices Program aims to provide timely access to medical devices that improve the treatment or diagnosis of life-threatening or debilitating human diseases or conditions.
Steve Lufkin, CEO of Selux Diagnostics, commented, "This third 510(k) clearance for Selux marks a significant advancement in infectious disease care. 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."
James S. Lewis II, PharmD, FIDSA, co-director of antibiotic stewardship at Oregon Health and Science University and chair of the CLSI Antimicrobial Susceptibility Testing Subcommittee, remarked, "The infectious disease community has eagerly awaited innovative technology to bolster our fight against difficult to treat infections. This clearance, coupled with the Selux NGP System, marks a significant leap forward."
For more information on the Selux NGP System, visit www.seluxdx.com.
Acknowledgment
This platform has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); and Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800013C.
About Selux Diagnostics
Selux Diagnostics is transforming patient care by accelerating the selection of personalized antimicrobial therapy for all infectious disease patients. This advance will save lives, shorten hospital stays, and combat the growing antibiotic resistance epidemic by decreasing the overuse of broad-spectrum agents. Learn more at www.seluxdx.com.
The Selux Next Generation Phenotyping (NGP) System includes:
Positive Blood Culture (PBC) Separator
Selux Inoculator
Selux Analyzer
Selux Gram Negative and Gram Positive Panels
Source: Selux Diagnostics
