Cytovale® Announces Commercial Launch of IntelliSep® Sepsis Test, the First-of-its-Kind Diagnostic Tool for Emergency Departments

SAN FRANCISCO--(BUSINESS WIRE)-- CytoVale^®, a pioneering medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced today the U.S. commercial launch of the IntelliSep^® sepsis test following FDA 510(k) clearance in December 2022. Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, is the first U.S. medical center to adopt IntelliSep for emergency department (ED) use. The test aids in the rapid diagnosis of sepsis for adult patients with signs and symptoms of infection, providing results in under 10 minutes.

“Sepsis is one of the most common conditions impacting emergency departments in the United States, and there has not been a timely test to identify sepsis early until now,” said Hollis O’Neal, MD, Medical Director of Research at Our Lady of the Lake Regional Medical Center and Critical Care Physician at LSU Health Sciences Center. “With the IntelliSep test, we can deliver the right care to the right patients at the right time and we are excited to be the first hospital in the country to implement this technology. I’m really excited for what the future brings.”

The IntelliSep test is a groundbreaking diagnostic tool that categorizes patients into three bands according to their probability of sepsis based on a standard blood draw. The results may equip providers with a tool to optimize clinical outcomes and empower hospitals to improve resource utilization and achieve operational excellence. IntelliSep may also support hospital efforts to meet guidelines set by the Centers for Medicare & Medicaid Services (CMS) for timely sepsis treatment, known as SEP-1.

Sepsis is the leading cause of death worldwide and is responsible for more than 350,000 deaths every year in the United States alone—more than opioid overdoses, prostate cancer, and breast cancer combined.^1,2 Quickly recognizing sepsis is critical to saving lives because the risk of death can increase by as much as eight percent each hour the condition is undiagnosed and untreated. As many as 80 percent of these deaths could be prevented with rapid diagnosis and treatment – making early detection critical to improving clinical, operational, and financial outcomes.¹

“The launch of the IntelliSep test is a huge moment in our fight against the devastating impact of sepsis,” said Cytovale co-founder and CEO Ajay Shah. “We know early detection and diagnosis is key, and we’re 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.”

Our Lady of the Lake Health is part of FMOLHS, which includes 10 hospitals across Louisiana and Mississippi. Cytovale is working to launch IntelliSep across the broader FMOLHS network and an expanded clinical network through the health system’s partnership with Louisiana State University. The company is also in discussions with additional hospital systems across the U.S. so that the impact of IntelliSep on early sepsis identification and patient risk stratification may be extended to additional emergency departments seeking such a solution.

About IntelliSep^®

Cytovale’s^® flagship diagnostic tool, IntelliSep, helps providers recognize sepsis and supports critical time-sensitive clinical decisions through its efficient 10-minute testing period, ease of use, integration into established care processes, and low-cost structure.

IntelliSep is pioneering a new way of quickly and accurately analyzing white blood cells to assess a patient’s probability of sepsis. The test is designed to simply and clearly determine probability of sepsis using a biomechanical evaluation of white blood cells collected from a standard blood draw.

About Cytovale^®

Cytovale is committed to improving human health by pioneering early detection technologies powered by insightful assessment of immune activation. Made up of an extraordinary team of life scientists, engineers, clinicians, and dreamers, Cytovale intends to accelerate the time it takes to get from triage to life-saving therapies. For more information, please visit www.cytovale.com. For updates, follow Cytovale on LinkedIn and Twitter.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50119C00072.

About Our Lady of the Lake Health

Our Lady of the Lake Health is a not-for-profit Catholic healthcare ministry based in Baton Rouge, Louisiana, with more than 7,500 employees committed to serving the Capital Region and building a healthy community through excellence in patient care and education. With an 800-bed Regional Medical Center, a dedicated Children’s Hospital, a 78-bed hospital in Gonzales, Louisiana, two freestanding emergency rooms in outlying parishes, and a 600+ provider Physician Group, Our Lady of the Lake Health provides comprehensive healthcare services for common to complex conditions. Our Lady of the Lake Regional Medical Center is a primary teaching site for graduate medical education programs in partnership with LSU, and is recognized in the areas of heart and vascular, trauma and emergency care, stroke, cancer care, minimally invasive procedures, and more. Our Lady of the Lake is part of the Franciscan Missionaries of Our Lady Health System and is driven by its mission to serve all God’s people, especially those most in need. For more information, visit ololrmc.com.

1. What Is Sepsis?, Sepsis Alliance (2022)

2. Sepsis Awareness Study Summary Report, Radius Global Market Research (2019).

View source version on businesswire.com: https://www.businesswire.com/news/home/20230801800143/en/