FDA Recognition for Rapid Sepsis Diagnostic
Scanogen Inc., a molecular diagnostics company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its rapid assay designed to identify bloodstream infection pathogens directly from patient samples, according to company announcements.
Transforming Sepsis Diagnosis and Treatment
The FDA’s Breakthrough Device designation recognizes technologies with potential to provide more effective diagnosis or treatment of life-threatening conditions, sources indicate. This designation is expected to expedite the development and regulatory review of Scanogen’s diagnostic assay, which represents a major advance in sepsis management. Reports suggest sepsis affects more than 1.7 million Americans annually and contributes to over 350,000 deaths.
Revolutionary Technology Platform
Scanogen’s first product leverages its proprietary SMART (Single Molecule And Rapid Tethering) technology platform to enable rapid, accurate detection of infectious diseases. The company’s flagship assay targets bloodstream infections in sepsis patients, delivering species-level identification results in just two hours—a dramatic improvement over the one to five days typically required by current blood culture-based methods, according to the report.
Potential Healthcare Impact
Analysts suggest that by enabling timely and targeted antimicrobial therapy, the test could significantly improve patient outcomes while curbing the overuse of broad-spectrum antibiotics and reducing hospital costs. With sepsis care reportedly exceeding $50 billion annually in the U.S., Scanogen’s technology could generate substantial healthcare savings while transforming infection management standards.
Clinical Validation and Funding
“This FDA recognition underscores the clinical need for faster, more accurate sepsis diagnostics and validates the potential impact of our platform,” Dr. Al Celedon, Founder and CEO of Scanogen, stated in the announcement. “Our goal is to empower clinicians with actionable results in hours rather than days—because every hour counts when treating sepsis.”
In addition to the FDA designation, sources indicate Scanogen has secured multiple research grants from the National Institutes of Health supporting development of its SMART platform and clinical validation. The company is reportedly raising a Series A round to fund pivotal clinical studies and advance the technology toward market launch.
About Scanogen
Scanogen Inc. is a Maryland-based company developing breakthrough molecular diagnostic technologies for rapid pathogen detection and antimicrobial susceptibility testing. Its proprietary platform enables single-molecule detection directly from clinical samples, providing highly sensitive and specific results in significantly less time than conventional methods require, according to company information available at www.scanogen.com.
The original announcement can be viewed at: https://www.businesswire.com/news/home/20251015749718/en/
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