Cytovale®, a trailblazer in the realm of medical diagnostics with a dedication to propelling early detection technologies for the swift diagnosis of rapidly progressing and immune-mediated diseases, has taken a momentous step by introducing the IntelliSep® sepsis test for commercial availability in the United States. This significant milestone comes after receiving FDA 510(k) clearance. Notably, the Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, has become the inaugural U.S. medical facility to adopt IntelliSep for use within its emergency department (ED).
The IntelliSep test is designed to deliver results within an impressive 10-minute window, serving as a valuable tool for promptly diagnosing sepsis in adult patients who exhibit signs and symptoms of infection. This development is of paramount importance, given that sepsis poses a substantial challenge in emergency departments across the United States, and a timely diagnostic solution has been lacking until now. The introduction of the IntelliSep test empowers healthcare providers to administer timely and appropriate care to the precise patients in need, representing a pioneering advancement in patient care technology.
Distinguished by its innovative approach, the IntelliSep test employs a sophisticated categorization system that classifies patients into three distinct probability bands for sepsis based on their clinical presentation. These rapid and actionable results equip healthcare providers with a valuable resource to optimize clinical outcomes, enabling hospitals to enhance resource allocation and achieve operational excellence. Furthermore, the IntelliSep test has the potential to support hospitals in meeting the timely sepsis treatment guidelines outlined by the Centers for Medicare & Medicaid Services (CMS), commonly known as SEP-1.
Sepsis, a significant global health concern responsible for over 350,000 annual deaths in the United States alone, ranks as a leading cause of mortality. Rapid identification is crucial, as untreated sepsis escalates the risk of death by as much as eight percent per hour when left undiagnosed. Prompt diagnosis and intervention have the potential to prevent up to 80 percent of these fatalities, underscoring the pivotal role of early detection in enhancing clinical, operational, and financial outcomes.
The launch of the IntelliSep test marks a momentous stride in combating the devastating impact of sepsis. Cytovale remains dedicated to expanding the reach of IntelliSep across the broader FMOLHS network, fostering an extended clinical network through a strategic partnership with Louisiana State University. Concurrently, discussions are underway with various prominent hospital systems across the U.S., with the aim of extending the transformative benefits of IntelliSep to additional emergency departments seeking a robust sepsis identification solution.
IntelliSep, the flagship diagnostic innovation developed by Cytovale, revolutionizes the analysis of white blood cells to accurately assess the probability of sepsis. Leveraging a biomechanical evaluation of white blood cells obtained from a standard blood draw, IntelliSep delivers a streamlined and comprehensible determination of sepsis likelihood. Its rapid 10-minute testing period, seamless integration into established care protocols, and cost-effective structure exemplify the cutting-edge attributes of this groundbreaking technology.