Sepsis is a serious condition where the immune system becomes unbalanced due to underlying infection(s) that lead to multiple organ failure and in 23% of cases, death, especially if not diagnosed early and treated promptly (Vincent, 2016). It is one of the most prevalent and deadly, yet misdiagnosed (Vincent, 2016), medical conditions. It was recently described that Sepsis in 2017 caused 49 million cases annually and was responsible for 11 million deaths (nearly 20% of all deaths). It is also the cause of the most deaths from severe COVID-19 disease. (Rudd, 2020)

What causes Sepsis?

A simple infection in the lungs, urinary tract, pelvis or abdomen can lead to sepsis (Cawcutt, 2014). An infection typically results in inflammation or tissue swelling which prevents it from spreading to the rest of the body. In some patients the response is dysregulated and actually acts against the body. In this case the infection can spread quickly resulting in widespread inflammation and immune suppression, one type of which is called cellular reprogramming, in which the body’s immune cells literally “forget” how to respond to infection. It is this type of cellular amnesia that the Sepset-ER test detects. As a result, the blood flow is affected and thereby the oxygen reaching the lungs and tissues.

Current Burden of Sepsis Diagnoses

Current methods to diagnose sepsis take more than 24 hours by which time patients are often well on their way towards tissue damage, organ failure, and death.

In 2017, 1 in 5 deaths worldwide involved sepsis (Rudd, 2020). Early recognition and management of sepsis saves lives. With every hour in delay of antimicrobial treatment during sepsis, there is an increase in mortality rate by 8% (Kumar, 2006). To err on the side of caution, patients recognized as “possible sepsis” receive sepsis treatment (~50% of patients actually go on to severe sepsis). However, the early clinical signs and symptoms examined to recognize possible sepsis can be seen in a variety of other conditions. Blood culture results to diagnose sepsis can also take days and their sensitivity is low. Inaccurate diagnosis can lead to worse outcomes, including death, for patients who are discharged with unrecognized sepsis or severely septic and not admitted directly to the ICU. Triage is important, as physicians need to decide who can go home, be managed in the ER, or be sent to the Intensive Care Unit (ICU) immediately. Physicians need more accurate data to help guide decision-making about when treatment is urgently required.