Cytovale Inc, a San Francisco-based medical technology company, has snagged an additional $3.83 million in funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to conduct a pilot study of its Rapid Sepsis Diagnostic System for patients with potential respiratory infections, including SARS-CoV-2, the novel coronavirus responsible for COVID-19. The patented technology, which can diagnose sepsis in less than 10 minutes, could speed up triaging and treatment of critically ill patients suspected of having a life-threatening condition.
The study will get underway immediately, led by Hollis O’Neal, a pulmonary disease specialist with LSU Healthcare Network Pulmonary-Critical Care, Our Lady of the Lake Regional Medical Center, in Baton Rouge, La. Early results could be available within 60 days, depending on how quickly patients are enrolled.
Large unmet need
Roughly 1.7 million Americans develop sepsis each year, and nearly 270,000 die as a result. The condition occurs when the body launches an extreme response to infection, triggering a cascade of changes that quickly can damage multiple organs, resulting in organ failure and, in many cases, death.
“Mortality from sepsis increases as much as 8% for every hour that treatment is delayed,” Ajay Shah, Cytovale’s co-founder, and CEO told BioWorld, adding that as many as 80% of sepsis deaths could be prevented with early detection and treatment.
Cytovale’s system is designed to measure immune cell activity associated with the dysregulated host response in sepsis. “In less than 10 minutes, each patient’s unique signature is compared to established profiles of robustly constructed multidimensional disease signatures, reduced by machine learning techniques, to determine a diagnostic score, reportable to the clinician within minutes,” Shah explained.
By contrast, current methods can pose challenges to early diagnosis, with doctors relying on vital sign readings, blood lactate levels, and other laboratory tests. Delays in care, already life-threatening, are raising new concerns with the coronavirus outbreak.
Novel coronavirus has ‘upped the ante’
“COVID-19 has upped the ante for critical care providers in terms of rapid diagnosis and has helped raise awareness among the general public about how serious infectious diseases – and the immune response to them – can be. It has also brought the issue of resource preservation to the forefront,” he said. “We are optimistic that our technology can be a part of the solution by helping providers make informed decisions quickly to treat sepsis patients who need it, spare those who don’t, and, ultimately, help save lives.”
O’Neal underscored the urgency of the research in light of the current pandemic. “We are looking for any advantage over COVID-19 as Louisiana emerges as a hot spot,” he said. “We are optimistic that this system could be part of the way critically ill patients are evaluated in the short and long term.”
Cytovale plans to enroll up to 300 patients who present to the emergency department with potential respiratory infections, including SARS-CoV-2. “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,” O’Neal said.
Researchers at the Korea Basic Science Institute, Korea Research Institute of Chemical Technology, and collaborators have published an article on the development of graphene-based test for SARS-CoV-2, the virus causing COVID-19, from nasopharyngeal swabs. They have determined it can detect SARS-CoV-2 in clinical samples at a concentration of 242 copies per ml and greater, a significant achievement.
Current diagnostic tests for COVID-19 utilize RT-PCR, amplifying the SARS-CoV-2 RNA from patient samples so tiny amounts of virus can be detected. It takes at least 3 hours, including methods for RNA preparation. The researchers who initiated this new study wanted to develop a faster test directly from patient swabs, without sample preparation steps.
The pilot study will be followed by a larger clinical trial to support a 510(k) submission to the U.S. FDA., Shah said.