Design and results of clinical trials that led to FDA clearance of SeptiCyte™ LAB published in the American Journal of Respiratory and Clinical Care Medicine
SEATTLE, May 9, 2018 /PRNewswire/ — Immunexpress, Inc. today announced the publication in the American Journal of Respiratory and Clinical Care Medicine of the design and results of clinical trials validating SeptiCyte™ LAB in the discrimination of sepsis from non-infectious systemic inflammatory response syndrome (SIRS) in the Intensive Care Unit (ICU) of hospitals. Distinguishing between sepsis and SIRS is clinically challenging due to strong similarities in patients’ symptoms. Early recognition and treatment of sepsis will lead to better patient outcomes, as patients with sepsis need immediate medical attention, including the administration of antibiotics. Sepsis is the leading cause of death in US hospitals and the most expensive condition treated in the United States, costing an estimated $US24 billion per annum1.
“Misdiagnosis of SIRS for sepsis is a problem for clinicians across the country, resulting in over prescription of antibiotics and increased costs for a hospital system,” said Russell R. Miller, MD, MPH, FCCM, of Intermountain Healthcare. “The validation of SeptiCyte™ LAB to distinguish between sepsis and SIRS in patients suspected of sepsis is a promising step. Rapid discrimination of these two seemingly similar clinical diagnoses could decrease the abundance of improperly prescribed antibiotics, leading to cost savings and, potentially, a decrease in the development of antibiotic resistant bacterial infections.”
A previous validation study on SeptiCyte™ LAB reported the performance in 345 critical care patients from a European population (ROC AUC 0.89-0.95). 2 This publication examined an additional, broader prospective clinical study involving ~450 critical care patients, representing both U.S. and European populations. SeptiCyte™ LAB was able to discriminate patients with either SIRS or sepsis better than other currently available tests or clinical parameters (ROC AUC of 0.82-0.89). In this trial, SeptiCyte™ LAB was able to identify every patient that went on to have a positive blood culture. SeptiCyte™ LAB does not correlate to disease severity, but rather to the presence of infection. Further, SeptiCyte™ LAB was moderately synergistic with other clinical and diagnostic parameters available within the first 24 hours of ICU admission (ROC AUC 0.86-0.92).
Most current sepsis diagnostic methods rely on isolating and identifying a causative pathogen. However, blood culture takes at least 24 hours to obtain a result and less than 50% of blood cultures from septic patients are positive. As a result, clinicians prescribe antibiotics promptly as soon as they suspect sepsis which is unnecessary or even counter-productive in cases that turn out to be SIRS. An alternative diagnostic approach to sepsis is to measure specific biomarkers of the host immune response to infection. Results of such tests can be obtained within a timeframe that affects clinical decision making.
“SeptiCyte™ LAB is able to deliver a clinically meaningful result to the physician in 100% of cases within the first 24 hours of admission,” said Rolland D. Carlson, PhD, President and Chief Executive Officer of Immunexpress. “The FDA clearance of SeptiCyte™ LAB was an important step in our continued refinement of SeptiCyte™. SeptiCyte™ is being translated to the Biocartis Idylla™ platform, a near-patient testing technology with the aim of reducing the test turnaround time to less than 75 minutes direct from blood and with hands-on-time of less than 5 minutes. Clinicians will be able to access better diagnostic information for patients suspected of sepsis within a clinically actionable timeframe.”
SeptiCyte™ LAB is the first host-response gene-expression assay cleared by the FDA as an aid for diagnosis of sepsis. SeptiCyte™ LAB uses a patient blood sample to measure the specific response of four genes to infection and is currently in a manual laboratory kit form with a turnaround time of ~6 hours. Test results are reported in terms of the probability of a patient having sepsis. Staunton, O., Staunton, C. The Urgency of Now: Attacking the Sepsis Crisis. Critical Care Medicine 2018; 46: 809-810  McHugh, L. et al. PLOS Med. 2015 Dec 8;12(12):e1001916. doi: 10.1371/journal.pmed.1001916.
Immunexpress is a Seattle-based molecular diagnostic company committed to improving outcomes for patients suspected of sepsis. Immunexpress’ SeptiCyte™ technology rapidly quantifies, directly from whole blood, specific molecular markers from the patient’s own immune system – the ‘host response’. SeptiCyte™ LAB, recently cleared by the FDA, is the first of its kind in using the host immune system to differentiate systemic inflammatory response syndrome (SIRS) and sepsis. Detecting the host’s response to infection has the potential to differentiate infection earlier, faster and more accurately than finding the invading pathogen because it is independent of whether or not the pathogen is present in the sample. Immunexpress’ pipeline includes several sample-to-answer assays for near patient testing.
For more information visit http://www.immunexpress.com/.
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