EpiDisease uses about €1.9 million in CDTI-backed EU funds to validate a sepsis test

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EpiDisease, a Valencian company founded in 2014 as a spin-off of the Universitat de València, INCLIVA and the CIBER network of the Instituto de Salud Carlos III, is developing HistShock IVD. It is an in vitro diagnostic kit that uses mass spectrometry to measure histones H2B and H3 and activated protein C in plasma. The aim is to tell sepsis apart from other non-infectious hyperinflammatory conditions and to flag early which patients are most likely to deteriorate. Knowing that a patient has sepsis is one thing. Knowing who will need intensive care in a few hours is the part the company cares about most.

The project received about €1.9 million from CDTI Innovación through the Seal of Excellence, paid for with EU recovery (MRR) funds. CEO José Luis García said the money covered recruiting 480 patients across several hospitals for a multicentre clinical performance study, alongside analytical validation and regulatory preparation. In García's words: "Discovering something interesting is only the beginning."

The next steps are to finish the performance evaluation and prepare a technical file under the EU in vitro diagnostics regulation. Industrialisation, scale-up and CE-IVD marking come after that. Separately, EpiDisease is working with Matisse Pharmaceuticals of the Netherlands on eHISTOCURE, a Eurostars-funded project. It is studying HistShock as a companion diagnostic for isupartob sodium, an experimental Matisse treatment.