HISTSHOCK - En - Epidisease

HISTSHOCK for the diagnosis and prognosis of sepsis, septic shock, and DIC

EpiDisease is developing technologies for the early diagnosis of sepsis, patient stratification based on severity and prognosis, and monitoring of treatment response.

HistShock is an IVD kit for measuring circulating histone levels (H3 and H2B) using mass spectrometry in plasma samples. Histones have been validated as biomarkers for diagnosing, stratifying by severity, and monitoring sepsis, septic shock, and the progression of disseminated intravascular coagulation (DIC).

HistShock has already demonstrated its effectiveness in clinical trials in real-world settings, published and peer-reviewed by the scientific community, to:

significantly reduce the number of false positives in sepsis diagnosis,

differentiate sepsis from other non-infectious hyperinflammatory processes by using non-septic ICU patients with similar symptoms

HistShock helps predict the progression from sepsis to septic shock, and can contribute to identifying patients at high risk of developing Disseminated Intravascular Coagulation (DIC). The latest breakthrough has been the demonstration of its potential to identify patients immediately after admission who will require life support therapies (mechanical ventilation and renal replacement therapy), helping to anticipate therapeutic interventions in critically ill patients.

Current Development Status

EpiDisease has developed a prototype of the HistShock IVD test and validated it in a clinical trial with 140 patient samples.
The HistShock technology is patented, and the patent has been granted in Europe (EP3535587), Japan (2019-546057), the United States (16/346,978), China (2017800822173), and Hong Kong (62020004691.5).
EpiDisease is currently validating the technology in an international multicenter clinical performance trial to prepare the technical documentation to obtain CE-IVD marking during 2025. The trial began in January 2024 and will conclude in the second quarter of 2025.
The project “Enhanced diagnosis and therapeutic options for patients with sepsis and septic shock using HistSHOCK IVD” has received funding from CDTI through the SME Instrument program with the Seal of Excellence from the Horizon Europe EIC Accelerator.
The project has been funded by CDTI with a grant of €1,904,650.30, and its implementation period runs from January 2023 to June 2025.

With the funding and support of:

Niveles cut-off de H2B de HISTSHOCK

SepAST

SepAST is a medical software web tool based on machine learning algorithms (European registration number 018645153), which uses biomarkers and clinical data to:

predict the clinical progression of patients with sepsis,
anticipate patient responses to treatment

SepAST thus contributes to the implementation of predictive and precision medicine in ICUs. EpiDisease has developed the prototype in a pilot study with 140 patients.

User Case de HISTSHOCK

A patient presents at the Emergency Department with one or more diffuse symptoms such as tachycardia, elevated temperature, or altered mental status, which clinically suggest a possible case of sepsis. A 10 µl sample of peripheral blood is taken to be analyzed with the HISTSHOCK test in order to confirm the diagnosis and severity of sepsis, enabling the application of personalized measures. Moreover, this result will allow for prognosis of the risk of progression to more severe conditions such as septic shock or DIC, making it possible to intervene preventively and alter the course of sepsis progression. As HISTSHOCK is a dynamic test, the effects of interventions on the course of the disease can be effectively monitored, allowing clinical interventions to be tailored to each patient’s response and resources to be adapted to actual needs. It is estimated that worldwide there are 149 million suspected cases of sepsis each year.

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