Looking for a clinical site where to validate our urine-based breast cancer test

We are looking for a clinical partner — ideally, a certified breast cancer centre, university hospital gynaecology department, or GCP-compliant clinical research facility — to join BlueScan-EU, a Horizon Europe-backed interregional project validating The Blue Box®: a non-invasive, urine-based early breast cancer detection device achieving 88.42% sensitivity (vs. 73% mammography), particularly for women with dense breast tissue. The partner will act as a co-investigator site in a multi-site clinical performance study (ISO 14155 / IVDR Annex XIV), contributing patient recruitment (≥200 participants over ~18 months from their breast screening programme), urine sample collection per standardised SOP, and local ethics submission. All protocols, devices, training, and data management infrastructure (REDCap) are provided by TBB. The study is observational and non-interventional — no additional procedures beyond standard-of-care mammography are required from patients.

Ideal partners have access to ≥1,000 breast screening patients per year, existing GCP/ICH-compliant clinical research infrastructure, and experience with investigational medical device studies. In return, partners gain a direct role in bringing a potentially transformative diagnostic to their patient population.