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SeptiCyte LAB sets its sights on sepsis
SEATTLE—Immunexpress, Inc. has announced today the publication in 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 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 $24 billion per year.
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 and possibly 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 the first host-response gene-expression assay cleared by the FDA as an aid for diagnosis of sepsis. The assay 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 around 4 - 6 hours. Test results are reported in terms of the probability of a patient having sepsis. SeptiCyte LAB does not correlate to disease severity, but rather to the presence of infection.
“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). This most recent publication examines a broader prospective clinical study involving 447 critical care patients, representing both US and European populations. SeptiCyte LAB was able to differentiate patients with either SIRS or sepsis better than any other currently available tests or clinical parameters. In this trial, SeptiCyte LAB identified every patient that went on to have a positive blood culture, and was moderately synergistic with other clinical and diagnostic parameters available within the first 24 hours of ICU admission (ROC AUC 0.86-0.92).
According to this new study, “In receiver operating characteristic [ROC] curve analysis, SeptiCyte LAB had an estimated area under curve [AUC] of 0.82-0.89 for discriminating sepsis from non-infectious systemic inflammation. In a forward logistic regression analysis, the diagnostic performance of the assay was improved only marginally when used in combination with other clinical and laboratory variables, including procalcitonin.”
“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.”