Proteotype Launches Innovative €3 Million Study for Multi-Cancer Detection and Home Blood Collection

Introduction to the INNOVATOR Study

Proteotype Diagnostics Unipessoal LDA, a notable player in cancer diagnostics, has announced the launch of its ambitious clinical study named INNOVATOR, which has received funding of €3.023 million. This project aims to expand the evidence base for their cutting-edge multi-cancer detection test, Enlighten®, while also evaluating the feasibility of collecting blood samples at home. A major focus of this study is to ensure accessibility and convenience for individuals undergoing cancer screening.

Objectives and Goals of the Study

The INNOVATOR study is set to broaden the validation of the Enlighten® test, which is based on detecting the host's response to tumor development. Initially rooted in the UK's MODERNISED project, which assesses 10 cancer types within real-world NHS contexts, INNOVATOR will extend its reach to cover 12 cancer types across multiple countries: Portugal, Spain, and Germany. With a goal to recruit around 2,000 participants, the study will include approximately 1,200 individuals diagnosed with cancer, and 800 control subjects varying from symptomatic to asymptomatic groups.

Funding and Support

This ambitious initiative is supported by approximately €2.116 million stemming from the COMPETE 2030 program, part of Portugal’s commitments towards enhancing healthcare innovation, co-funded by the European Union. This funding will aid in solidifying the pathway for Proteotype's plans for CE marking, ensuring that their advancements are compliant with regulatory expectations.

Methodology and Approach

Throughout the study, paired venous and capillary blood samples will be collected utilizing a CE-marked Tasso® collection device. One of the pivotal aspects of this study is to ascertain the comparability between the collected samples, paving the way for a future laboratory test capable of using blood sourced from home collections.

Leadership Insights

Wesley Sukdao, the CEO and Co-Founder of Proteotype, emphasizes the motivation fueling this project, stating, "Having grown up in poverty in South Africa and experienced the loss of dear family members due to late cancer detection, our mission at Proteotype is clear. Scientific advancements need to be accessible to everyone, regardless of their socio-economic background."

Dr. Emma Yates, Proteotype’s Chief Scientific Officer and Co-Founder, reinforces the study's broadened focus, asserting, "INNOVATOR will help us evaluate the Enlighten® test across various cancer types, demographics, and methods of sample collection, which is vital in understanding how well biological results translate across different settings."

Scientific Validation

Professor Gonçalo Bernardes, the Scientific Advisory Board Chair and Co-Founder, commented on the significance of INNOVATOR, describing the momentum behind Enlighten® as reflecting the deep understanding of the body’s responses to cancer, transitioning from theoretical insights to substantial clinical validations. He remarks, “This initiative combines rigorous scientific principles with a clear translational objective, aiming to develop a scalable test.”

Professor Luís Costa, the Chief Investigator of INNOVATOR, also highlighted the study's importance, stating, “This extensive, multi-country study is essential for generating clinically meaningful evidence while addressing practical barriers to cancer detection.”

Recruitment and Future Prospects

Set to commence on October 1, 2026, the INNOVATOR project aims to begin participant recruitment following the necessary ethical reviews, regulatory approvals, and site readiness. The study is projected to conclude by the end of 2028. This initiative also signifies an expansion of Proteotype’s team based in Torres Vedras, encompassing various roles across clinical, regulatory, and engineering sectors.

About Proteotype Diagnostics

Proteotype Diagnostics is dedicated to pioneering diagnostic solutions aimed at revolutionizing the early detection of multiple cancers and personalized medicine. Their flagship product, Enlighten®, is under evaluation as a user-friendly, scalable solution for multi-cancer detection, designed to cultivate earlier diagnosis and improve clinical decision-making processes.

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