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BARDA Awards up to $30M to Cue Health for Influenza, Respiratory Pathogen Test Development

NEW YORK (GenomeWeb) – The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority has awarded up to $30 million in funding and options to San Diego-based Cue Health to accelerate the development and regulatory validation of over-the-counter and professional-use influenza and multiplex respiratory pathogen diagnostic cartridges for its health monitoring system, the company said today.   

The monitoring system centers around an electronically connected diagnostic device that enables a range of in-home and in-clinic diagnostics, Cue Health said. It uses a custom designed reader to test clinical samples in a disposable test cartridge and then sends the results to a mobile application that provides access to features such as telemedicine consultations for consumers and prescribing capabilities for physicians. 

The firm anticipates developing an influenza cartridge to detect influenza A and B and a cartridge to detect and differentiate between multiple respiratory pathogens. 

In a separate announcement earlier this week, the firm said that it raised more than $45 million in Series B financing that it will use to complete development of its first set of diagnostic products and fund a set of clinical studies to obtain US Food and Drug Administration 510(k) clearance for them. 

According to Cue, its disposable cartridges use advanced DNA/RNA amplification and immunoassay chemistry to generate digital information that is sent to a mobile device.