U.S. Centers for Medicare & Medicaid Services (CMS) has granted an International Classification of diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) code for Immunexpress' host response molecular test for sepsis, SeptiCyte® RAPID.
FirstHealth of the Carolinas, a nonprofit health system licensed for four hospitals in North Carolina, will use Immunexpress’ SeptiCyte Rapid test to help differentiate sepsis-positive cases from patients with infection-negative systemic inflammation.
“The early accurate diagnosis of sepsis can be challenging, but recent advancements in FDA-cleared lab tests have introduced new tools that may enhance earlier diagnosis," said Kenneth E. Remy, MD, MHSc, MSCI, FCCM, Center Director, the Blood, Heart, Lung, and Immunology Research Center and the Ellery Sedgwick, Jr. Chair and Distinguished Scientist in Cardiovascular Research at University Hospitals in Cleveland/Case Western Reserve University. AACC-2023-Sepsis 072023
FirstHealth is among other early adopters integrating the recently FDA cleared SeptiCyte RAPID® test into their hospital sepsis clinical workflow to address diagnostic uncertainty and improve sepsis awareness and bundle compliance.
Despite its prevalence and severe consequences, diagnosing sepsis remains a significant challenge in the healthcare industry. Delve into an enlightening interview with Richard Brandon, the Chief Scientific Officer at Immunexpress, a company at the forefront of revolutionizing sepsis diagnostics.
The adoption of innovative approaches, such as SeptiCyte RAPID, to aid in sepsis diagnosis is expected to provide benefits to patients, clinical utility to physicians and financial benefits to hospital and health systems.
SeptiCyte Rapid was included in Infection Control Today’s April product locator. “With SeptiCyte RAPID, we are testing for the first clinical signs of sepsis and generating actionable results quickly. This is critically important because mortality risk increases by 8% as each hour goes by,” said Rollie Carlson, PhD, CEO of Immunexpress.
For patients initially classified as indeterminate and then reassessed by a forced diagnosis, SeptiCyte RAPID significantly differentiated between SIRS (mean result or SeptiScore® 5.6) and sepsis (mean SeptiScore 7.3) (p=1.31e-07).
This study demonstrates that SeptiCyte RAPID is not only a more accurate sepsis diagnostic tool compared to other conventional rapid diagnosis methods but can serve as a crucial first step in the diagnostic and treatment paradigm for patients suspected of sepsis using the Sepsis-3 framework.
A study in the journal Viruses validates the use of SeptiCyte® RAPID as a tool to measure disease severity in COVID-19 patients, in comparison to a reference method based on chest computed tomography (CT) imaging.
At the Association for Molecular Pathology annual meeting and exposition this week, Immunexpress launched a rapid molecular diagnostic test that could enable ruling in or ruling out sepsis in one hour.
In this Q&A, Immunexpress Chief Executive Officer Dr Rolland Carlson and Chief Scientific Officer Dr Richard Brandon discuss key aspects for molecular diagnostic discovery and development platforms, including how to best leverage microarray and next-generation sequencing (NGS) tools.
SeptiCyte® RAPID EDTA blood compatible cartridges were recently launched in the European market, representing a significant development milestone for the identification of pathogens associated with sepsis. This press release and the associated blog posts explore the significance of this development.
This article from Technology Networks includes an interview with Rolland Carlson, PhD, the CEO of Immunexpress. Rolland describes the paradigm shift in sepsis diagnosis as well as the specifics of how SeptiCyte® RAPID provides a faster and accurate diagnosis, allowing physicians to quickly rule-in or rule-out sepsis.
Learn more about the process of getting the lab test for sepsis, SeptiCyte® RAPID, cleared by the FDA. This article from Med Device Online also includes tips for obtaining a 510(k) FDA Clearance for other medical use products.
At the 32nd ECCMID, Immunexpress and collaborators at Hospital Foch, France, shared research demonstrating that SeptiCyte® RAPID sepsis test can distinguish between COVID-19 patients showing higher extents of lung damage as defined by lung CT scans from those with a milder presentation.
In this DNA Weekly interview, Immunexpress CEO Dr. Rollie Carlson, discusses why the company is tackling sepsis, explains the challenge of diagnosing sepsis, and details how SeptiCyte® RAPID helps. He also discusses how SeptiCyte® RAPID allows hospital systems to improve their sepsis management quality scores.
Often difficult to diagnosis, sepsis remains a leading cause of morbidity and mortality among intensive care unit (ICU) patients. SeptiCyte® RAPID is the first FDA-cleared sepsis diagnostic to differentiate sepsis from non-infectious systemic inflammation to aid in rapid sepsis diagnosis within approximately one hour.
This Medical Device Network article highlights our FDA-cleared sepsis diagnostic SeptiCyte® RAPID. The fast sepsis test addresses “a critically unmet need in the ICU,” said Immunexpress Chief Medical Officer, Dr. Roy Davis. SeptiCyte® technology aids physicians in distinguishing sepsis from -infection-negative (SIRS) systemic inflammation in critically ill patients.
In this interview with 10 News Brisbane, Dr. Adam Irwin, physician, and senior lecturer of pediatric infectious disease at the University of Queensland, details how deadly a sepsis diagnosis can be for children. Richard Brandon, Chief Scientific Officer of Immunexpress, shares the development of a one-hour sepsis test, SeptiCyte® RAPID, that is awaiting Australian regulatory approval.
SeptiCyte® RAPID is a sepsis test that uses peripheral blood gene expression biomarkers to provide accurate sepsis diagnosis in patients presenting with clinical signs of systemic inflammation. Data was presented detailing the superior performance of SeptiCyte® RAPID in differentiating sepsis from non-infectious inflammatory responses at the 2021 IDWeek Conference.