IDENTIFYSENSORS INITIATES FDA SUBMISSION PROCESS FOR DIGITAL DIAGNOSTICS PLATFORM

Regulatory authorization will signal the first electronic technology to detect a disease

CLEVELAND, May 20, 2025 /PRNewswire/ -- IdentifySensors Biologics, a leading developer of digital diagnostic technologies, has initiated the FDA review process by submitting a pre-EUA for emergency use authorization of a rapid Ebola test on the company's new Check4 platform.

When authorized, the diagnostic advancement will be the first platform that detects Ebola virus using nanomaterials on an electronic semiconductor. The company is developing similar biosensors for a wide range of infectious diseases that can be identified through the electrical reactions of DNA and RNA – down to the molecular level for high levels of accuracy.

Digitizing diagnostics on a small Bluetooth device offers a wide range of health-care advantages, including rapid results, database connectivity, location mapping, data collection, greater accessibility and facilitating faster treatment times. The platform is intended to be more user friendly and less expensive than similar tests.  

Unlike current molecular tests, which largely require laboratory work with skilled technicians, the Check4 platform is intended to be used virtually anywhere, any time. The company plans an ongoing pipeline of FDA submissions for infectious diseases, bacterial infections and other diseases that can be detected through genetic biomarkers.    

To date, the company has been issued 26 patents and raised $20 million to commercialize the technology. It is seeking additional funding and strategic partners to expand research and development.

"This is the new internet of things for diagnostics," said IdentifySensors CEO Greg Hummer. "Current molecular tests are old, slow, expensive and require skilled labor. Our rapid detection platform solves that through electronic circuits that connect instantly to cloud-based algorithms and healthcare software systems."

About IdentifySensors Biologics
IdentifySensors Biologics is a nano-biotech company driving a shift in molecular diagnostics from a hardware-heavy, laboratory-based delivery model to a low-cost, portable software-based delivery platform. The advancements leverage new nanomaterials in semiconductors and bioinformatics. For more information visit www.identifysensors.com

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SOURCE IdentifySensors Biologics