IDENTIFYSENSORS BIOLOGICS ANNOUNCES NEW CLINICAL STUDIES GROUP TO VALIDATE DIGITAL DIAGNOSTIC DEVICES

The company is preparing for extensive clinical studies during the 2023 cold-and-flu season

CLEVELAND, June 28, 2023 /PRNewswire/ -- IdentifySensors^® Biologics, a leading developer of digital diagnostic technologies, announces the formation of the company's new Clinical Studies Group, responsible for testing new diagnostic devices in preparation for FDA submissions.

The group has started preparing for an extensive clinical study this fall of two multiplex respiratory devices intended to detect and differentiate SARS-CoV-2, Influenza A, Influenza B and respiratory syncytial virus in saliva. One device is for over-the-counter sales, and the other is for point-of-care use.

The company's goal is to advance diagnostics beyond current chemical testing, such as PCR and antigen tests, by introducing rapid solid-state electronic biosensors that connect to the cloud. The devices are intended to reduce costs and testing time, while increasing sensitivity and flexibility for clinicians and consumers.    

As part of the announcement, the company has appointed Ricardo De Medeiros, Ph.D. to the newly created position of associate director of clinical affairs. Medeiros brings more than 20 years of experience in scientific and clinical research. He holds a doctorate in virology and a post-doctorate in immunology. Medeiros has authored more than 30 peer-reviewed articles in virology, immunology, cancer biology, stem cells and cardiovascular research. 

Check4^®, the brand name of the diagnostic devices planned for clinical studies this year, are part of a larger testing platform intended to be functionalized for a wide variety of additional pathogens throughout the next several years.

"In preliminary studies we have seen encouraging results of this new technology," said Greg Hummer M.D., IdentifySensors^® co-founder and CEO. "We are excited to test these devices and move forward with additional targets that detect a wide range of infections."

Additional pathogen targets are intended to include Ebola and Marburg virus; diarrheal infections, including norovirus, rotavirus and adenovirus; Hepatitis C; HIV; methicillin-resistant staphylococcus aureus; and chlamydia and gonorrhea. The Check4^® diagnostic device is not yet approved for use or sale in the United States.

About IdentifySensors^® Biologics
IdentifySensors Biologics is the leading developer of digital diagnostic technologies on printed solid-state electronic biosensors. The company is principally focused on developing real-time pathogen detection for direct diagnosis and rapid results. For more information visit www.identifysensors.com

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SOURCE IdentifySensors Biologics