Wednesday, August 02, 2023
Cytovale®, a leading medical diagnostics company focused on advancing early detection technologies for fast-moving and immune-mediated diseases, has announced the commercial launch of the IntelliSep® sepsis test in the United States. The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the test in December 2022. Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, is the first medical center in the U.S. to adopt the IntelliSep® test for use in their emergency department.
The IntelliSep® test aids in the rapid diagnosis of sepsis for adult patients displaying signs and symptoms of infection, providing results in less than 10 minutes. It categorizes patients into three bands based on their probability of sepsis, utilizing a standard blood draw. This breakthrough diagnostic tool empowers healthcare providers to optimize clinical outcomes, improve resource utilization, and achieve operational excellence. It also aligns with the guidelines set by the Centers for Medicare & Medicaid Services (CMS) for timely sepsis treatment (SEP-1).
Sepsis is a critical global health issue, responsible for over 350,000 deaths annually in the U.S., surpassing the combined mortality of opioid overdoses, prostate cancer, and breast cancer. Rapid recognition and treatment of sepsis are crucial, as the risk of death can increase by up to eight percent for each hour that the condition remains undiagnosed and untreated. Early detection is essential, as it has the potential to prevent up to 80 percent of these fatalities, significantly improving clinical, operational, and financial outcomes.
Ajay Shah, co-founder, and CEO of Cytovale expressed enthusiasm for the impact of the IntelliSep® test on sepsis management, stating, "The launch of the IntelliSep test is a significant moment in our fight against the devastating impact of sepsis. We know early detection and diagnosis are key, and we are proud to have a partner in Our Lady of the Lake and look forward to seeing IntelliSep's impact at other Franciscan Missionaries of Our Lady Health System (FMOLHS) hospitals."
Cytovale aims to expand the availability of the IntelliSep® test throughout the broader FMOLHS network, which includes 10 hospitals across Louisiana and Mississippi. They are also working to collaborate with Louisiana State University to introduce the test to an extended clinical network. Additionally, discussions are underway with other hospital systems across the United States to extend the impact of IntelliSep® in early sepsis identification and patient risk stratification to more emergency departments seeking such a solution.