Policy & Regulation
Cytovale Receives Additional BARDA Funding to Evaluate Rapid Sepsis Diagnostic in Persons Under Investigation for COVID-19
23 April 2020 - - US-based medical technology company Cytovale, Inc has expanded a partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant secretary for Preparedness and Response at the US Department of Health and Human Services, to conduct a pilot study for Cytovale's Rapid Sepsis Diagnostic System for patients with potential respiratory infections, including those with SARS-CoV-2, responsible for COVID-19, the company said.

The study, led by Dr. Hollis O'Neal, M.D., LSU Healthcare Network Pulmonary-Critical Care, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA, will commence immediately. Initial data is expected to be available within 60 days, depending on enrollment.

Sepsis is a serious public health threat, killing approximately 270,000 Americans each year.

The condition is the result of an extreme response to infection that can lead quickly to organ failure and death. Minutes can become a matter of life and death in the accurate diagnosis, triage and treatment of critically ill patients with suspected sepsis.

By looking at the structure of immune cells through high-speed imaging, machine learning and microfluidics, Cytovale's patented technology can diagnose sepsis in under 10 minutes with the goal of enabling timely and accurate triage in the emergency department, filling a crucial unmet need in rapid sepsis diagnosis.

BARDA is continuing to fund advanced research and development activities to support the FDA 510(k) clearance for the Cytovale Rapid Sepsis Diagnostic System.

BARDA and Cytovale are demonstrating a continued commitment to their public-private partnership, first announced in October 2019, with BARDA now contributing an additional USD 3.83m of the USD 5.9m total estimated cost to continue validation and advanced research, including the pilot study of COVID-19 patients.

Cytovale will fund the remaining research and development costs for this study.

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.
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