Proteotype Unveils Innovative €3 Million Study to Enhance Multi-Cancer Detection through Home Blood Testing

Overview of the INNOVATOR Study

Proteotype Diagnostics Unipessoal LDA has announced the launch of a significant clinical study dubbed the INNOVATOR, which boasts a budget of €3.023 million. This ambitious initiative aims to strengthen the scientific evidence for Enlighten®, a blood-based multi-cancer test, as well as to investigate the feasibility of home blood collection methods. This study is crucial as it seeks to enhance the early detection of multiple cancers, potentially making life-saving diagnostics more accessible.

Study Objectives and Structure

The primary goal of the INNOVATOR study is to validate Enlighten® across 12 different cancer types while assessing whether capillary blood collection can simplify the process of testing. By doing this, Proteotype aims to demonstrate that cancer tests can be performed reliably using samples collected in a home setting, which could lead to a more convenient healthcare experience for patients.

Supported by €2.116 million from the COMPETE 2030 program under Portugal 2030 and co-funded by the European Union, the study plans to recruit approximately 2,000 participants across multiple European countries including Portugal, Spain, and Germany. The recruitment will consist of approximately 1,200 individuals diagnosed with cancer and another 800 participants serving as controls—representing both symptomatic and asymptomatic groups.

Methodology and Sample Collection

The INNOVATOR study is designed to collect paired blood samples utilizing a CE-marked Tasso® device, allowing researchers to compare venous and capillary samples. This comparison is essential for determining if capillary collections can produce reliable results that support the development of a practical Enlighten® test based on blood samples collected at home. The comprehensive nature of the study, which is expected to involve about 3,350 participants across four countries, will help broaden the validation of this test across various healthcare systems and demographics.

Contributors and Their Perspectives

Wesley Sukdao, the CEO and co-founder of Proteotype, emphasized the personal motivation behind the study, sharing his experiences of growing up in a low-income environment in South Africa and the impact of late cancer diagnoses on his family. Sukdao stated, "Scientific progress only changes lives when people can access it. INNOVATOR moves us closer to our goal of making advanced cancer testing affordable, accessible, and practical, regardless of where someone lives or the resources available to them."

Dr. Emma Yates, the Chief Scientific Officer and co-founder, highlighted the broader range of cancers and populations that will be evaluated through this project, reinforcing the critical nature of understanding how well biological responses translate across various sample types and clinical situations.

Professor Gonçalo Bernardes, Chair of Proteotype's Scientific Advisory Board, expressed optimism regarding the study's framework, stating, "INNOVATOR combines strong science with a clear translational objective, focusing on the development of a test that can be deployed on a large scale."

Timeline and Future Outlook

Set to commence on October 1, 2026, the INNOVATOR study's participant recruitment will initiate once all ethics, regulatory approvals, and site preparations are completed. The entire research project is expected to be wrapped up by the end of 2028. In conjunction with the study's ambition, Proteotype will also expand its team in Torres Vedras, Portugal, with vacancies for multiple critical roles ranging from Senior Trial Manager to engineering positions.

About Proteotype Diagnostics

Proteotype Diagnostics is dedicated to pioneering advancements in diagnostic methodologies, particularly focusing on developing multi-cancer detection tests and personalized treatments by measuring the body's response to tumors. With Enlighten® at the forefront of its offerings, the company aims to revolutionize diagnostic accessibility and enhance clinical decision-making globally.