IdentifySensors Biologics has initiated the FDA pre-EUA (Emergency Use Authorization) submission for its rapid Ebola test, marking a pivotal step in the commercialization of its Check4 digital diagnostics platform. This innovative system is the first of its kind to use nanomaterials embedded on an electronic semiconductor to detect the Ebola virus. The platform digitizes molecular diagnostics by identifying electrical reactions from DNA and RNA—providing lab-quality accuracy at the point of care. This breakthrough merges biotechnology with electronics, opening the door to rapid, scalable disease detection on a global scale.

The Check4 device is a compact, Bluetooth-enabled diagnostic tool designed for real-time use in virtually any setting. Unlike conventional molecular tests that require laboratory infrastructure and skilled technicians, Check4 delivers fast results without the need for specialized personnel or facilities. It enables cloud connectivity, automated data capture, and even geolocation mapping—features that make it ideal for managing outbreaks, tracking disease spread, and improving accessibility in underserved areas. Its cost-efficiency and ease of use position it as a disruptive tool in global health, particularly in remote or emergency scenarios.

The FDA submission represents a major milestone for IdentifySensors, which has secured 26 patents and raised $20 million to date. With plans for additional submissions targeting a range of infectious diseases and bacterial infections, the company is building a comprehensive diagnostic ecosystem that could redefine how and where testing is performed. As CEO Greg Hummer noted, “This is the new internet of things for diagnostics”—a vision of fast, decentralized testing that could significantly improve treatment timelines, reduce healthcare costs, and enhance outbreak response worldwide.

MedTech Spectrum's Summary

First Electronic Ebola Test Submission : IdentifySensors’ Check4 platform is the first to detect Ebola using nanomaterials on a semiconductor, enabling rapid, lab-free molecular diagnostics.

Portable, Real-Time Disease Detection : The Bluetooth-enabled device delivers instant results with cloud connectivity, eliminating the need for labs or skilled technicians and expanding accessibility.

Scalable Solution for Global Health :With 26 patents and ongoing development for multiple pathogens, the platform aims to transform outbreak response and point-of-care testing worldwide.