Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Cytovale launches trial of rapid sepsis test

June 15, 2021 By Nancy Crotti

CytovaleDiagnostics company Cytovale recently announced the first enrollment in a clinical trial of a test to assess the potential for sepsis in the emergency department.

The Cytovale IntelliSep test is designed to provide actionable answers directly from a blood sample in under 10 minutes. The prospective study titled Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department Protocol (CV-SQuISH-ED) will involve at least 600 patients at multiple U.S. health centers, according to San Francisco-based Cytovale. Its primary endpoint is a comparison to sepsis as adjudicated by an independent panel of physicians, the gold standard for sepsis determination. Other endpoints include common severity of illness and utilization metrics.

The first patients were enrolled at Our Lady of the Lake Regional Medical Center in Baton Rouge, La., and Harborview Medical Center in Seattle, Wash. Other enrolling centers will include University of Missouri Health Care in Columbia, Mo., and Wake Forest Baptist Health in Winston-Salem, N.C.

“Early and reliable strategies to identify sepsis remain elusive, complicating physicians’ efforts to implement sepsis care as quickly as possible. Since time-to-treatment for sepsis is measured in lives saved, we need a tool to mitigate diagnostic uncertainty and facilitate early sepsis care,” said Dr. Daniel Henning, a University of Washington emergency medicine physician and site principal investigator at Harborview Medical Center, in a news release. “CV-SQuISH-ED, the latest trial evaluating this type of novel early detection sepsis testing, may give us exactly that kind of tool.”

Sepsis is the number one cause of death in hospitals, taking the lives of 270,000 people every year in the U.S. alone – more than opioid overdoses, prostate cancer, and breast cancer combined, according to a 2014 study published in JAMA. Mortality from sepsis increases as much as 8% with every hour of delayed treatment, and as many as 80% of septic shock patients survive with early identification and initiation of appropriate antibiotics, according to a separate study published in the journal Critical Care Medicine.

The clinical validation study builds on two previous studies of Cytovale’s IntelliSep test. “We are hopeful that CV-SQuISH-ED will confirm the findings of our previous work with this important technology,” said Dr. Hollis O’Neal, critical care physician at Louisiana State University Health Sciences Center and national principal investigator for the study. “Sepsis takes a heavy toll on our patients and a tool like this could make a big difference.”

Related Articles Read More >

This is a Boston Scientific illustration of its Eluvia drug-eluting stent for treating peripheral artery disease or PAD.
How Boston Scientific is advancing its PAD-treating drug-eluting stent
An image of the Pulse Biosciences CellFX nsPFA 360° catheter.
Is nanosecond pulsed field ablation the next big step for PFA?
A photo of Medtronic's LINQ II implantable cardiac monitor.
Lessons from Medtronic’s Define AFib study of implantable cardiac monitors
An image of Abbott's Infinity deep brain stimulation (DBS) implants and leads.
As Abbott studies DBS for depression, what might be next?
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe