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Disagreement in Sepsis Diagnosis is Associated with Significant Antibiotic Overprescription

SEATTLE, Feb. 26, 2019 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostics company based in Seattle, announced the publication of a study, in the Journal of Intensive Care, demonstrating the challenge physicians face in making accurate and consistent clinical diagnoses of sepsis in intensive care patients.

Sepsis is an illness caused by the body's overwhelming immune response to an infection, which can lead to tissue damage, organ failure and death. Early diagnosis and rapid intervention can alter the course of treatment and reduce the probability of permanent bodily damage. i-ii The correct identification of sepsis in patients is challenging. iii Data from the publication demonstrate, on average, a 30% discordance in diagnosis between the initial and the final physician assessment of sepsis, implying that up to one in three patients may be incorrectly treated under the standard method of sepsis diagnosis. iv The study also finds that the presence of respiratory clinical symptoms contributed to the greatest disagreement in diagnoses. iv 

Bert K. Lopansri, M.D., Infectious Disease Specialist at Intermountain Medical Center and University of Utah School of Medicine and lead author on the publication, comments, "This study demonstrates the challenges clinicians of varying levels of experience face in distinguishing sepsis from non-infectious causes of systemic inflammation. In many cases, disagreement persisted amongst experts highlighting limitations of clinical parameters and existing diagnostic tools. Given the diagnostic uncertainties, antibiotic use was very common even when not seemingly indicated."

In patients ultimately deemed to not have sepsis, close to 60% had been inappropriately prescribed a systemic antibiotic treatment. iv Additionally, over 90% of patients with indeterminate clinical diagnoses were treated with antibiotics. The study's in-depth bioinformatic analysis could not identify underlying clinical characteristics that led to the decisions to prescribe antibiotics in these cases, suggesting that physicians initiate antibiotic treatment prior to establishing a definitive patient diagnosis. iv

Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress, added, "The data emphasize the immediate need for rapid and objective diagnostic tools for sepsis, reiterating the urgency with which Immunexpress is developing and commercializing our SeptiCyte™ technology. Immunexpress is committed to providing clinicians with a highly accurate, impartial diagnostic tool to help determine the correct clinical diagnosis upfront, which is especially important for the 30% of patients with a diagnosis that was later deemed incorrect after treatment had begun. We hope to ease the burden on clinicians, enabling them to rapidly and accurately diagnose and treat patients, while also decreasing the need for blanket antibiotic prescriptions."

About Immunexpress
Immunexpress is a leader in the development of whole-blood diagnostic tests for the detection of sepsis using host gene expression biomarkers. Immunexpress' SeptiCyte™ technology rapidly quantifies, directly from whole blood, specific molecular markers from the patient's own immune system. SeptiCyte™ LAB was recently cleared by the FDA and is the first of its kind 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 the pathogen is present in the sample. Immunexpress' pipeline includes several sample-to-answer assays for near patient testing.

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Media Contacts:
Maggie Beller
Russo Partners, LLC
(646) 942-5631


i Dellinger, R.P., et al. Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 39, 165-228 (2013).

ii Bai, X., et al. Early versus delayed administration of norepinephrine in patients with septic shock. Crit Care. 18, 532 (2014).

iii Vincent, J.L., et al. The Clinical Challenge of Sepsis Identification and Monitoring. PLoS Med. 13, e1002022 (2016).

iv Lopansri, B.K., Miller, R.R., et al. Physician Agreement on the Diagnosis of Sepsis in the Intensive Care Unit: Estimation of Concordance and Analysis of Underlying Factors in a Multicenter Cohort. J Intensive Care. (2019). DOI: 10.1186/s40560-019-0368-2

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SOURCE Immunexpress, Inc.

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Last Updated: 26-Feb-2019