We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
LGC Clinical Diagnostics

Download Mobile App




First One-Hour, Direct-from-Blood Sepsis Test Receives FDA Clearance

By LabMedica International staff writers
Posted on 01 Dec 2021

A fully automated diagnostic tool quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis. More...

Immunexpress, Inc. (Seattle, WA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SeptiCyte RAPID test as an aid in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis.

The increasing incidence of sepsis, which has accelerated with the COVID 19 pandemic, is well recognized and has been generally attributed to the growing prevalence of chronic conditions in aging populations. The clinical presentation of sepsis is often hard to identify early; fever is not always present, and it can often go unrecognized clinically for extended periods. Sepsis remains a leading cause of morbidity and mortality among intensive care unit (ICU) patients. For each hour that treatment initiation is delayed after diagnosis, sepsis-related mortality increases by approximately 8%. Therefore, maximizing effective care requires early recognition and initiation of treatment protocols.

SeptiCyte RAPID is the first FDA cleared test to differentiate sepsis from non-infectious systemic inflammation to aid in a sepsis diagnosis within approximately one hour for patients suspected of sepsis. SeptiCyte RAPID contains all the reagents needed for quantification of gene expression using a reverse transcription polymerase chain reaction (PCR) to determine the relative expression levels of host response genes directly from whole blood. The process is fully automated in a user-friendly, hands-free format, and a result is obtained in one hour.

"SeptiCyte RAPID has the potential to transform sepsis diagnosis, addressing a critically unmet need in the ICU," said Roy Davis, M.D., Ph.D., Chief Medical Officer of Immunexpress. "SeptiCyte RAPID has been evaluated in hospitals since 2019. Major hospital systems with which we have worked are anxiously waiting to incorporate this into the current diagnostic tool set, allowing clinicians to make swift and accurate clinical decisions, ultimately improving patient outcomes."

"It has been a long journey to transfer our clinically proven novel biomarker technology from our eight hour FDA-cleared SeptiCyte LAB product in 2017, to the advanced one hour sample-to-answer Biocartis Idylla testing platform," added Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. "This FDA clearance could not have been achieved without the dedication of the Immunexpress team, the support of our investors, and our clinical partners around the globe."

Related Links:
Immunexpress, Inc. 


Gold Member
Fully Automated Cell Density/Viability Analyzer
BioProfile FAST CDV
Serological Pipet Controller
PIPETBOY GENIUS
New
Automated PCR System
OnePCR
New
Respiratory Syncytial Virus Test
OSOM® RSV Test
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: Schematic overview of the deep learning-based circulating exosome analysis for lung cancer detection (Photo courtesy of Chuan Xu, Cheng Jiang)

Liquid Biopsy Approach to Transform Diagnosis, Monitoring and Treatment of Lung Cancer

Lung cancer continues to be a major contributor to cancer-related deaths globally, with its biological complexity and diverse regulatory processes making diagnosis and treatment particularly difficult.... Read more

Pathology

view channel
Image: The Aiforia Breast Cancer Grading AI solution is CE-IVD marked (Photo courtesy of Aiforia Technologies)

Clinical AI Solution for Automatic Breast Cancer Grading Improves Diagnostic Accuracy

Labs that use traditional image analysis methods often suffer from bottlenecks and delays. By digitizing their pathology practices, labs can streamline their work, allowing them to take on larger caseloads... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.