BARDA announces partnership expansion with Cytovale, Inc. for continued development of Cytovale’s rapid diagnostic system for sepsis as part of COVID-19 pandemic response

Pilot study includes patients with suspected respiratory infections, including COVID-19, to evaluate use for predicting the likelihood of viral sepsis

BARDA Response

BARDA and Cytovale, Inc. are expanding their partnership for additional advanced research and development of a diagnostic system being designed to diagnose sepsis in less than 10 minutes.

Cytovale’s rapid diagnostic system is a deformability cytometry platform, meaning that it analyzes the biomechanical properties of immune cells; this method may enable early and rapid diagnosis of sepsis. Receiving results in less than 10 minutes would enable timely and accurate triage in the emergency department, allow for more effective identification and treatment of sepsis, and help optimize use of valuable hospital resources.

To validate this rapid diagnostic system in identifying patients at risk of viral sepsis, Cytovale’s pilot study specifically will enroll patients suspected of respiratory infections, including COVID-19 patients, prior to conducting full validation studies. This pilot study is an important step in evaluating the system’s performance to rapidly identify the likelihood of sepsis in these patients in the emergency department.

The pilot study represents the expansion of a larger contract, first launched in September 2019, which includes executing analytical and clinical validation studies and preparing for manufacturing scale-up and validation, all of which are necessary for the U.S. Food and Drug Administration to consider clearance of the diagnostic system.

This specific study is part of BARDA’s Rapidly Deployable Capabilities program to identify and pilot near-term innovative solutions for COVID-19, leveraging the development of Cytovale’s rapid diagnostic system under BARDA’s Division of Research Innovation and Venture (DRIVe) Solving Sepsis Program.

This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.

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Cytovale, based in San Francisco, Calif., is a medical technology company dedicated to revolutionizing diagnostics using cell mechanics and machine learning, and applying this first to sepsis, a condition whose early detection dramatically improves patient outcomes. For more information visit: