Scanogen Receives FDA Breakthrough Device Designation for Rapid Sepsis Test

Scanogen Inc., a molecular diagnostics company, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its rapid assay designed to detect bloodstream infection pathogens directly from patient samples.

The designation is intended for technologies that could improve the diagnosis or treatment of life-threatening or seriously debilitating diseases. 

It is expected to accelerate the development and regulatory review of Scanogen’s assay, which targets sepsis—a condition affecting over 1.7 million people in the U.S. each year and causing more than 350,000 deaths.

Scanogen’s test uses the SMART (Single Molecule And Rapid Tethering) technology platform to deliver fast, accurate, and cost-effective identification of infectious agents. 

The assay can provide species-level results in just two hours, compared with the one to five days typically required by conventional blood culture methods.

By enabling timely, targeted antimicrobial therapy, the test has the potential to improve patient outcomes, reduce overuse of broad-spectrum antibiotics, and lower hospital costs.
 
Scanogen has also received support from the National Institutes of Health (NIH) for further development and is raising funds to advance pivotal clinical studies and prepare for market launch.