Cytovale, Inc., a medical technology company dedicated to revolutionizing diagnostics using cell mechanics and machine learning, announced today the expansion of 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 U.S. 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 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.
“Sepsis is a potentially deadly outcome of COVID-19. The goal of this study is to determine if we can diagnose sepsis quickly and accurately in potential COVID-19 patients and appropriately triage them with the Cytovale technology,” said Dr. O’Neal.
“We are looking for any advantage over COVID-19 as Louisiana emerges as a hot spot. We are optimistic that this new system could be a part of the way critically ill patients are evaluated in the short and long term.”
“The COVID-19 pandemic has added urgency to bringing our innovative technology to market,” said Ajay Shah, Ph.D., co-founder and CEO of Cytovale. “We are grateful to BARDA for the critical funding that will help demonstrate the value of this technology and to the teams at Our Lady of the Lake and LSU for leading the Cytovale Rapid Sepsis Diagnostic System research effort during this unprecedented time.”
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 $3.83 million of the $5.9 million 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.
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