The LASERBLOOD Horizon Europe project will expand its consortium by integrating COMPLEAR, significantly boosting the project's implementation and impact. COMPLEAR's inclusion will establish a comprehensive regulatory framework for the development of the laser-based In Vitro Diagnostic (IVD) technology for the early diagnosis of pancreatic cancer, the project's primary goal. With COMPLEAR expertise, LASERBLOOD will develop the technology in accordance with the European Union (EU) In Vitro Diagnostic Regulation (IVDR - Regulation EU 2017/746) and United States (US) Food and Drug Administration (FDA) requirements, streamlining future approvals and market adoption. This alignment with global standards will enhance the credibility, safety, and market readiness of LASERBLOOD’s technology. COMPLEAR's expertise will boost the development of the IVD prototype, enriching the consortium’s knowledge in IVD regulations and promoting effective transnational collaboration. In turn, COMPLEAR will gain valuable experience in scientific research and management of important projects, enhancing its role in the European research community. Its participation will support excellence in Widening countries and its integration into the LASERBLOOD consortium will expand the project’s outreach by fostering new networks in the diagnostics sectors and cross-border knowledge exchange. In addition, COMPLEAR will provide access to new talent pools and stakeholders. This collaboration will improve the overall quality and reach of the project.

Pancreatic ductal adenocarcinoma (PDAC) is a deadly form of cancer that is on the rise due to various factors, including an aging population and unhealthy lifestyles. Regrettably, PDAC is among the top cancer killers, with a dismal five-year survival rate of less than 10%. The lack of adequate screening programs is a significant factor contributing to this dire statistic. However, the identification of PDAC in its early stages could help reduce the mortality rate by as much as 80%. The project LASERBLOOD (Biophotonic Nanoparticle-enabled Laser Blood Test for Early Detection of Pancreatic Cancer) aims to develop an in vitro diagnostic test based on the fluorescence lifetime fingerprint of the personalized protein corona, offering critical information at every stage of PDAC progression. The protein corona (PC) is a coating of bio-molecular substances surrounding nanoparticles when exposed to biofluids. It is both personalized and disease-specific, making it an ideal marker to monitor the variation of nanoparticle PC and correlate it to the development of PDAC. The analysis will use fluorescence lifetime (FL) analysis, a non-invasive, reactant-free, and real-time technique. In the initial phase, the consortium will utilize a mouse model (MKC) to identify the FL fingerprint of protein corona at each stage of PDAC development. The MKC mouse model is genetically engineered to be bioluminescent and develop PDAC in a controlled manner. By linking the development of PDAC observed through bioluminescent imaging to the FL response of PC in blood samples, the consortium will provide an unprecedented fingerprint of the disease's progression from its first occurrence. At a second stage, the project will validate on humans the use of the FL fingerprint of protein corona as a tool for the early diagnosis of PDAC. The findings will provide the scientific and technological foundation for the development of an in vitro PDAC test for large scale screening of the population.