Selux Diagnostics Earns FDA Breakthrough Device Designation for Next Generation 'Phenotyping' (NGP) Platform for Positive Blood Culture and Sterile Body Fluid samples
Selux NGP now qualifies for expedited FDA review process as single-platform technology for rapid antimicrobial susceptibility testing (AST) for specified sample types
BOSTON, Sept. 28, 2021 /PRNewswire/ -- Selux Diagnostics, Inc., which is leading a new era in personalized diagnostics to combat superbug infections and fight antibiotic resistance, today announced that its Next Generation 'Phenotyping' (NGP) platform has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for positive blood culture and sterile body fluid samples.
"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," said Steve Lufkin, CEO of Selux. "The NGP technology is uniquely positioned to accelerate personalized therapy selection for patients while leading the fight against antibiotic resistance. We are honored by the FDA recognition of the Selux platform for these sample types."
Selux NGP is the only single-platform technology capable of delivering rapid AST results across all sample types with an unprecedented antibiotic menu. Selux's NGP technology delivers phenotypic AST from both Positive Blood Bottles and isolated colonies – which may provide actionable results to indicate which therapies may effectively treat a patient's infection.
The FDA created the Breakthrough Devices Program to provide patients and providers with timely access to medical devices by speeding up their development, assessment, and review process while preserving statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. The designated device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition.
In addition, Breakthrough Designation may provide reimbursement benefit, subject to ongoing CMS consideration of the proposed Medicare Coverage of Innovative Technology (MCIT) program.
"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," said Lufkin "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."
About the Selux Next-Generation Phenotyping Platform
The proprietary Selux technology uniquely provides targeted therapy results days faster than the current standard of care providing actionable information to inform patient treatment for all Infectious Diseases. Selux's NGP platform provides unprecedented speed-to-results and breadth of menu while meeting the accuracy, throughput, and cost effectiveness requirements of clinical microbiology laboratories and integrated healthcare systems.
Caution - The Selux platform is an investigational device, limited by federal law to investigational use
This platform has been funded in whole or part with federal funds from the U.S. Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201800013C.
About Selux Diagnostics
Selux Diagnostics is transforming patient care by offering <24-hour personalized antimicrobial therapy results for all Infectious Diseases patients. This advance will save lives, shorten hospital stays, and combat the growing antibiotic resistance epidemic by decreasing the overuse of broad-spectrum agents. The 5-year-old company is based on the opposite side of Boston, MA, from where it originated in a co-founder's attic. Learn more at www.seluxdx.com.
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SOURCE Selux Diagnostics, Inc.