Validation of Progranulin as Biomarker in Diagnostics and Prognosis of Sepsis

Informazioni relative al progetto

Vaprosep

ID dell’accordo di sovvenzione: 672801

DOI

10.3030/672801

Progetto chiuso

Data della firma CE 13 Aprile 2015

Data di avvio 1 Maggio 2015

Data di completamento 30 Settembre 2015

Finanziato da

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH
Germany

Periodic Reporting for period 1 - Vaprosep (Validation of Progranulin as Biomarker in Diagnostics and Prognosis of Sepsis)

Periodo di rendicontazione: 2015-05-01 al 2015-09-30

Sintesi del contesto e degli obiettivi generali del progetto

Sepsis is a complex, systemic and inflammatory host reaction to an infection. With worldwide 20-30 million cases, sepsis is regarded as a hidden epidemic. Because the clinical diagnosis is unreliable, there is a strong need for a reliable biomarker. Preliminary data prove that progranulin (PGRN) allows a highly sensitive and specific detection of sepsis, a timely monitoring of the disease course and a differentiation between viral and bacterial causes of the disorder.

Objectives of the feasibility study were the evaluation of the economic potential of PGRN in sepsis diagnostics and the development of a marketing strategy to implement its measurement in clinical routine.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

Key opinion leaders in the EU were contacted and 13 experts answered the structured interview, proving the strong need for a valid sepsis biomarker. Based on their recommendations a biomarker validation study protocol was developed and potential clinical partners were recruited. Regulatory and reimbursement analysis did not reveal any obstacles regarding successful market implementation. Also the feasibility study confirmed the economic advantages of PGRN as biomarker in reduction of the length of stay in the intensive care unit (500-1000€/day) and avoidance of unnecessary antibiotic therapy (10-500€/day). Analysis of production costs revealed that a price of PGRN measurement of 10€ is reasonable. Market potential of 6.2 Mio patients in the US and EU allows to achieve the break-even point and an ROI of 54% within nine years after project start based on a conservatively estimated market share of 10%. The marketing strategy to achieve this market share includes well known tools like scientific publications, congress participation and direct customer contact. The successfully validated PGRN measurement will be introduced in third level hospitals in the EU initially, followed by market access in the US. Long term strategy involves implementation of PGRN measurement also in second level hospitals to increase market penetration and revenues. Based on a strong intellectual property strategy this market is available only for Mediagnost. After PGRN is established as biomarker in sepsis diagnostics the subsequent strategic product development includes point of care systems.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

The feasibility study proofs that Vaprosep is a clinically and economically important and realistic project, which is worth further funding to realize the ambitious goals and improve medical care and economic growth.

Receiver operating characteristic curve showing sensitivity and specificity of PGRN as a biomarker