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EUREKA/Eurostars: Búsqueda de experiencia en desarrollo y validación de ensayos de diagnóstico basados en PCR en tiempo real (rt-QPCR) con diagnóstico in vitro (IDV) para enfermedades humanas

Resumen

Tipo:
Búsqueda de socios
Referencia:
RDES20170116001
Publicado:
06/02/2017
Caducidad:
06/02/2018
Resumen:
Una pyme española que ofrece servicios de diagnóstico molecular para diversas enfermedades humanas está interesada en participar en un proyecto Eurostar 2 - Eureka. La empresa busca pymes en Alemania y Francia con el fin de lanzar al mercado un kit de diagnóstico basado en PCR en tiempo real (rt-QPCR) y predecir el riesgo de desarrollar septicemia en pacientes con infarto de miocardio. Específicamente se desarrollará un producto de diagnóstico in vitro para la detección rápida (en menos de 4 horas) de mtDNA en sangre mediante PCR en tiempo real (rt-QPCR) como biomarcador para evaluar el estado de tolerancia inmune de pacientes con infarto de miocardio en unidades de cuidados intensivos. El objetivo es presentar una propuesta al programa Eurostars, con fechas límite en marzo y septiembre de 2017.

Details

Tittle:
EUREKA/Eurostars: expertise in the development and validation of real-time quantitative PCR (rt-QPCR) diagnostic assays with in vitro diagnostic (IDV) label for human diagnosis sought
Summary:
A Spanish SME that offers molecular diagnostic services for different human diseases is looking to present a Eurostar 2- Eureka project and looking for a SMEs in Germany and France to put into market a diagnostic kit based in Real Time Quantitative PCR (rt-QPCR) to predict the risk of developing sepsis in patients with myocardial infarction. The plan is to apply together to the Eurostars in 2017 (deadline March and September, 2017).
Description:

Myocardial Infarction (MI) is a very important medical problem in all developed countries. A higher incidence of sepsis has been described associated to this pathology, being sepsis in Intensive Care Units (ICU) a very important medical problem in all developed countries with an incidence ranging from 6 to 30% in ICUs. More than 50% of sepsis cases are diagnosed secondary to other diseases which gives an idea of the magnitude of this problem in developed countries, where the prevalence of MI is very high.
The lack of accurate diagnostic tools to predict which patients are at risk of sepsis complicates the management of the disease. The development of such prediction methods will have a tremendous social impact saving lives, reducing health costs, reducing the unjustified use of antibiotics, etc. especially in the European countries where MI has a clear clinical impact.
Mitochondrial DNA (mtDNA) is a potent biomarker for the diagnostic of acute damage by tolerance immune state in MI. When a person suffers a MI, tissue injury occurs when the cells are disrupted, is released into the bloodstream all kinds of debris, including remnants of mitochondria. It is well-known that mitochondria preserve important bacterial features and when a cell disruption occurs, and mitochondrial damage-associated molecular pattern molecules (DAMPs) arrive to bloodstream, starts an immune response against a "ghost enemy", after the initial response, the immune system goes into a state of tolerance to avoid an exacerbated response due to accumulation of different boost. In these patients, the problem is that if that time comes a real infection, the immune system is unable to respond, the infection becomes majority and ends in a sepsis.
A spanish molecular diagnostics company with experience in basic-clinical research as well as in detection of biomolecules and markers of different pathologies wants to present a project to Eurostart-eureka call.
The proposed solution will be to develop an in vitro diagnostic (IVD) product for the fast detection in less than 4 hours of mtDNA in blood by Real Time Quantitative PCR (rt-QPCR) as a biomarker for the evaluation of tolerant immune state in patients of MI to be used in intensive care units.
The specific aims of the project are the following:

· To perform a clinical trial to validate the quantification of mtDNA in the blood of MI patients as evaluation of the tolerance immune state and to predict the risk of developing secondary infections and sepsis.

· To develop the IDV kit based in the quantification of the mtDNA using rt-QPCR.

· To launch the developed IDV kit to the EU market.

The spanish SME will recruit the patients for the clinical trial, obtaining both the sample and the required clinical, statistical and regulatory data from MI patients to this study.

They are looking for technological partners in Germany and France with the ability and experience to manufacture and validate a Q-PCR kit. Subsequently, both companies will market the diagnostic kit; the collaboration agreement may include marketing exclusivity in the country of the partner company.

The call deadline is March 2017 and September 2017. EOI deadline is June 2017, but the company will prefer to submit on the first call, March 2017 so EOIs coming before January 2017 will be evaluated for the first call.

Advantages and Innovations:
Currently available IDV solutions in the market for the diagnosis of sepsis detect the presence of the microorganisms causing secondary infections or first signs of inflammation when there is an ongoing infection.

The project solution is an innovation in the diagnosis of sepsis since it is able to predict the risk of developing sepsis prior to the beginning of the microorganism colonization. It can differentiate patients with increased possibilities of developing sepsis from those who are not in risk by analyzing the levels of mtDNA biomarker in the blood of patients who suffered a MI using rt-QPCR, which is available in most of the hospitals. In addition, it can be applied to DNA obtained from blood or serum from patients which is easy to obtain.

Stage of Development:
Proposal under development
IPR Status:
Patents granted

Partner sought

Partner Sought:
They are looking for SME specialized in human diagnostic kits based in detection/quantification of biomarkers located in Germany and France. The partner must have expertise in the development and validation of real-time quantitative PCR (rt-QPCR) diagnostic assays with in vitro diagnostic (IDV) label for human diagnosis. The partner will process the samples (blood plasma) to obtain total DNA and will perform the rt-QPCR to determine the levels of mtDNA in those samples in order to validate the IVD kit. In addition, due to the experience of the partner, the manufacture the diagnostic kit that will be commercialized.
Type of Partnership Considered:
RDR

Client

Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
No
Languages Spoken:
English
Spanish

Dissemination

Restrict dissemination to specific countries:
France
Germany

Programme-call

Evaluation Scheme:
2 stage
Anticipated Project Budget:
500000
Coordinator Required:
No
Deadline for Call:
15/03/2017
Project Duration:
104
Weblink to the Call: