Cytovale announced today that its IntelliSep® test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.

"The ongoing COVID-19 pandemic has revealed how stretched our healthcare resources are and illustrated a need for tools and technologies to help ensure appropriate resources are available to support emergent cases,” said Dr. Hollis R. O'Neal Jr., a critical care physician at the Louisiana State University Health Sciences Center and a principal investigator of the study. “In these situations, a pathogen-agnostic assessment of the host response, such as Cytovale’s IntelliSep test, may assist clinicians in the risk stratification of persons under investigation for infection by providing a patient-centered, objective assessment of the state of immune activity."

“This execution of the final option in the contract will help us complete manufacturing ramp-up as we prepare to launch our IntelliSep test, making a reality of our vision for a critical, time-saving tool with the potential to change the way emergency departments recognize and treat sepsis,” said Cytovale co-founder and CEO Ajay Shah. “In addition to the financial investment, we believe the funding underscores the importance of these final manufacturing activities necessary to bring IntelliSep to market to address an unmet need and help physicians more quickly and accurately assess patients who may have this deadly and debilitating condition.”

Sepsis is the leading cause of death worldwide according to the World Health Organization, killing 11 million people each year, many of them children, and disabling many more. But while speedy diagnosis and treatment is crucial in combating sepsis, the medical profession has no reliable and speedy test for the condition...

Data Published in Journal Critical Care Explorations Evaluates Cytovale’s IntelliSep Test in Triaging Patients with High Risk of Sepsis, Morbidity and Mortality

SAN FRANCISCO--(BUSINESS WIRE)--Cytovale, a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases, today announced the first enrollment in a clinical trial of the Cytovale system and IntelliSep test to aid in the rapid assessment of potential for sepsis in the emergency department (ED).

SAN FRANCISCO--(BUSINESS WIRE)--Cytovale, a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune mediated diseases, today announced the publication of a study in the peer-reviewed journal PLOS ONE evaluating its IntelliSep test in the rapid diagnosis of sepsis in the hospital emergency department. Data from the study, “Development and validation of a cellular host response test as an early diagnostic for sepsis,” showed that Cytovale’s test has the potential to provide clinically actionable performance in distinguishing potentially septic patients.

Cytovale garners an AACC Academy’s Distinguished Abstract Award for study of its IntelliSep sepsis test, which utilizes routine blood draw samples, requiring minimal operator handling, and achieves a blood-to-answer turnaround time of less than 10 minutes

Cytovale Inc. will expand its partnership with the Biomedical Advanced Research and Development Authority, or BARDA, to examine the use of Cytovale’s Rapid Sepsis Diagnostic System for diagnosing sepsis in patients with potential respiratory infections, including COVID-19, according to a press release.

Hollis O’Neal, MD, pulmonary-critical care expert, Our Lady of the Lake, and the national primary investigator for the Cytovale early sepsis detection system, discusses sepsis and COVID-19 and provides an overview of his pilot study.

The Biomedical Advanced Research and Development Authority (BARDA) has hit an organization with Cytovale to build up a quick demonstrative framework for sepsis as a major aspect of the COVID-19 pandemic reaction.

Cytovale has received $3.8 million from HHS’ Biomedical Advanced Research and Development Authority (BARDA) for a study of its rapid-sepsis test for COVID-19 patients.