Bloodstream infections in sepsis progress quickly and demand rapid, precise diagnosis. Current blood-culture methods often take one to five days to identify the pathogen, leaving clinicians to treat blindly with broad-spectrum antibiotics. This delay can worsen outcomes in a condition responsible for more than 1.7 million cases and over 350,000 deaths annually in the U.S. A new rapid bloodstream infection assay now offers species-level answers within two hours, aiming to speed targeted antimicrobial therapy and reduce mortality.

Scanogen Inc.’s (Baltimore, MD, USA) SMART-ID BSI Assay is a rapid single-molecule test that analyzes whole blood to identify the pathogens that cause 95% of bloodstream infection cases within two hours. The assay is built on its SMART (Single Molecule And Rapid Tethering) technology, which leverages single-molecule detection to enable the direct identification of bloodstream infection pathogens from patient samples without waiting for culture growth. The platform is designed to deliver rapid, accurate, and cost-effective detection suitable for real-time clinical decision-making.

Scanogen’s flagship SMART-ID BSI Assay delivers a dramatic reduction in diagnostic turnaround time for bloodstream infections in sepsis patients compared with traditional blood-culture methods. The assay offers species-level identification results in just two hours, which is a dramatic improvement over the one to five days usually required by current blood culture–based methods.

The US FDA has now granted Breakthrough Device Designation for the company’s rapid assay designed to identify bloodstream infection pathogens directly from patient samples. The FDA designation recognizes the assay’s potential to improve the diagnosis of a life-threatening condition and allow for expedited development and regulatory review. The designation also reflects the technology’s capacity to shorten time to targeted therapy and support improved patient outcomes.

The implications for clinical care are significant. Timely pathogen identification is expected to reduce reliance on broad-spectrum antibiotics, lowering resistance risks while enabling precision-guided treatment. Hospitals may also benefit from reduced length of stay and lower overall care costs, particularly as sepsis management already exceeds USD 50 billion annually in the U.S. Scanogen plans to accelerate development of the assay under the Breakthrough program and advance toward clinical validation and eventual commercialization.

“This FDA recognition underscores the clinical need for faster, more accurate sepsis diagnostics and validates the potential impact of our platform,” said Dr. Al Celedon, Founder and CEO of Scanogen. “Our goal is to empower clinicians with actionable results in hours rather than days—because every hour counts when treating sepsis.”

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