Selux claims that NGP is the only single-platform technology capable of delivering rapid AST results across all sample types with extended antibiotic menu
FDA Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
Selux Diagnostics has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Next Generation Phenotyping (NGP) platform.
The NGP platform is designed to deliver phenotypic rapid antimicrobial susceptibility testing (AST) results from both positive blood samples and isolated colonies.
The technology is said to provide actionable results to determine effective therapies for the treatment of patients with infectious diseases.
Selux claimed that its NGP is the only single-platform technology that can deliver rapid AST results across all sample types with an extended antibiotic menu.
Selux CEO Steve Lufkin said: “While currently under review for our rapid antimicrobial susceptibility test (AST) system for isolated bacterial colonies, the FDA recognized the urgent need to perform AST directly from blood and other sterile body fluids by granting us Breakthrough Designation.
“The NGP technology is uniquely positioned to accelerate personalized therapy selection for patients while leading the fight against antibiotic resistance. We are honoured by the FDA recognition of the Selux platform for these sample types.”
The Boston-based company said that its technology offers targeted therapy results days faster than the current standard of care, facilitating treatment for all infectious diseases.
Also, the NGP platform offers superior speed-to-results and breadth of menu, with accuracy, throughput, and cost-effectiveness required for laboratories and healthcare systems.
FDA’s Breakthrough Devices programme is designed to accelerate the development, assessment, and review process for medical devices used in severe diseases or conditions.
The company has received federal funding support from the US Department of Health and Human Services (HHS), ASPR, and BARDA for the development of the platform.
Lufkin added: “Today’s delay of as much as 4+ days before AST results are available for the sickest patients is not optimal. The Selux platform is capable of testing up to 40 drugs in parallel, with room to expand as new therapies become available.
“Providing more rapid results for patients with drug-resistant infections may allow Physicians to prescribe targeted antimicrobial therapy much sooner, reducing hospital length of stays and help combat drug resistance.”