Immunexpress Presents Results Indicating the Utility of SeptiCyte™ for the Diagnosis of Sepsis in Critically Ill Children at the 45th Annual Society of Critical Care Medicine Congress
Additional Results from the VENUS A Study Further Validate SeptiCyte as a Diagnostic Assay for Sepsis in Critically Ill Adults
SEATTLE, Feb. 22, 2016 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company committed to improving outcomes for suspected sepsis patients, today announced the presentation of data on the utility of SeptiCyte™ LAB in both adult and pediatric populations to aid in the clinical assessment of sepsis in critical care patients. The two data presentations were given by Dr. Russell R. Miller, III of Intermountain Medical Center and Dr. Jerry J. Zimmerman of Seattle Children's Hospital at the 45th Annual Society of Critical Care Medicine Congress in Orlando, Fla.
Dr. Zimmerman's presentation demonstrated a preliminary validation of SeptiCyte LAB for differentiating sepsis from infection negative systemic inflammation in 63 critically ill children. This preliminary study found that, when tested in the Genotypes And Phenotypes of Pediatric SIRS and Sepsis (GAPPSS) trial cohorts, SeptiCyte LAB produced strong performance, comparable to that observed in adult populations.
Additionally, Dr. Miller presented data from the VENUS A study, the prospective pivotal study which serves as the basis for the FDA filing for the SeptiCyte LAB. SeptiCyte LAB was able to effectively distinguish between sepsis and infection negative systemic inflammation, a result which was not linked to measures of patient severity. This prospective study further validates the results from five patient cohorts published in PLOS Medicine in December.
"Our host response assay provides a probability of sepsis in 100% of cases in a matter of hours, greatly improving on the pathogen detection assays that can take days and often produce negative results that are not clinically actionable," said Dr. Roslyn Brandon, President and CEO of Immunexpress. "Dr. Zimmerman's work at Seattle Children's Hospital provides the first evidence that SeptiCyte may help identify sepsis in the pediatric setting. These promising results justify an expansion to a broader validation study in pediatric patients. Dr. Miller's results are the first from the VENUS A study which validates our technology as a diagnostic aid in adult suspected sepsis patients as we move toward FDA clearance of SeptiCyte LAB."
Sepsis is a life-threatening condition that arises when the body's response to infection damages its own tissues and organs. Sepsis diagnostics today aim to identify the pathogen only and therefore have serious limitations in respect of speed and sensitivity. The Immunexpress SeptiCyte solution evaluates the host immune response to aid clinicians in quickly and accurately diagnosing sepsis in patients suspected of sepsis.
About SeptiCyte™ LAB
SeptiCyte™ LAB quantifies directly from whole blood specific molecular markers from the patient's own immune system – the "host response." Immunexpress has validated hundreds of nucleic acid and protein expression biomarkers that, in different combinations, answer specific clinical questions about sepsis. Patented biomarkers, algorithms and analysis methods are used to interpret information about the septic host response.
About Immunexpress
Immunexpress is a Seattle-based molecular diagnostic company committed to improving outcomes for patients suspected of sepsis. Immunexpress's SeptiCyte™ technology quantifies directly from whole blood specific molecular markers from the patient's own immune system – the "host response." Detecting the host's septic immune response has the potential to identify sepsis earlier and more accurately than current sepsis diagnostics that focus on identifying the invading pathogen because it is independent of whether or not the pathogen is in the blood sample. Immunexpress's pipeline includes monitoring assays for readily available platforms, including point-of-care (POC) sample-to-answer instrumentation. For more information visit www.Immunexpress.com.
Follow Immunexpress on Twitter at twitter.com/Immunexpress and LinkedIn at www.linkedin.com/company/immunexpress-inc.
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SOURCE Immunexpress, Inc.
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