Breakthrough Diagnostic Platform to Rapidly Detect Life-Threatening Bloodstream Infections

Yeast bloodstream infections affect more than 30,000 patients in the U.S. each year and are associated with mortality rates exceeding 40%. Survival depends on rapid antifungal treatment, yet the current diagnostic gold standard, blood culture, requires one to five days. This delay can be fatal, highlighting the urgent need for faster, more reliable diagnostic tools to detect life-threatening infections at an earlier stage. Now, a breakthrough diagnostic platform could enable rapid testing for life-threatening bloodstream infections.

Scanogen (Baltimore, MD, USA) has developed an automated diagnostic platform powered by its proprietary Single Molecule and Rapid Tethering (SMART) technology. SMART is a revolutionary platform technology for ultra-sensitive and rapid detection of nucleic acids and microorganisms in body fluids. SMART technology unlocks entirely new diagnostic possibilities by enabling direct detection of nucleic acids without the need for amplification.

Scanogen automated diagnostic system is designed to deliver results directly from whole blood within two hours, eliminating the need for blood culture. Featuring a compact desktop instrument and disposable cartridge system, the platform offers a simplified workflow that ensures quick and accurate pathogen detection.

In recent validation studies, the platform demonstrated 96% sensitivity and 99% specificity. Importantly, it was also able to detect Candida auris, a pathogen classified as an urgent public health threat. These performance metrics underscore the system’s potential to significantly improve diagnostic speed and accuracy for fungal bloodstream infections. With timely pathogen identification, physicians can quickly initiate targeted antimicrobial therapy.

With support from a USD 2.9 million NIH Commercialization Readiness Pilot Program grant, funded by the National Institute of Allergy and Infectious Diseases (NIAID), Scanogen will focus on scaling reagent and cartridge production under FDA-compliant processes. The funding accelerates the pathway from laboratory development to widespread clinical adoption. Additional work will strengthen the software with cybersecurity and LIS integration while transferring the system into production.

These steps will position the company to launch pivotal clinical studies for regulatory clearance. Going forward, the technology has the potential to transform the standard of care for bloodstream infections by enabling earlier treatment and reducing mortality. Hospitals could integrate the system into existing diagnostic workflows, providing a practical, rapid-response solution to an urgent global health challenge.

“This funding is a major step toward bringing our rapid test to hospitals. Faster diagnosis means earlier treatment—and more lives saved,” said Dr. Al Celedon, Founder and CEO of Scanogen. “The new funding accelerates the pathway from laboratory development to widespread clinical adoption.”

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