Sepset is developing a point-of-care blood test for hospitals to identify septic patients in the emergency room (ER) and predict those who will have high risk for organ failure.
Drs. Bob Hancock and Olga Pena made a research breakthrough discovery that has substantial clinical implications (Pena, 2011; Pena, 2014). Their conclusions were informed by both a meta-analysis of 592 patients, including both pediatric and adult sepsis cohorts, and by an initial single-blinded prospective observational clinical study. Using a hypothesis-driven approach, they demonstrated that sepsis patients posses a gene expression signature characteristic of a biological phenomenon known as “Cellular Reprogramming” (CR) which is associated with immunosuppression. CR involves the reprogramming of immune cells to a state where they are unable to respond to microbial signatures in a way that triggers protective immune responses. The CR signature was present in patients suspected of sepsis as early as first clinical presentation (in the emergency department) and was able to identify which patient did or did not go into developing severe sepsis. Most importantly, the strong presence of the signature was associated with worse outcomes, including multiple organ dysfunction and ICU admission (Pena, 2014).
These observations are novel and fundamental, and have enormous implications in the management of sepsis, with respect to early diagnosis and prognosis, as well as supporting early application of appropriate therapies including antimicrobial and non-pharmaceutical (e.g. immunomodulatory) strategies.
Based on these findings, Sepset’s test will be able to identify early signs of cellular reprogramming and therefore the development of immunosuppression in patients during their first visit to the ER, allowing a more aggressive management to increase patient survival.
Advantages of the Technology
- Earlier diagnosis for sepsis at the time patients enter the ER and recognized as “possible sepsis”
- More accurate predictor for severity of sepsis (i.e. development of immune suppression and organ failure)
Dr. Hancock and his collaborators are currently initiating a large prospective, observational, multi-center international clinical study to statistically validate the gene signature.