The Blue Box

The Blue Box Biomedical Solutions SL

The Blue Box

Early-stage breast cancer detection from urine: pain-free, radiation-free

Barcelona, España

ESP

For-profit, including B-Corp or similar models

Breast cancer (BC) remains the leading cause of cancer-related deaths among women worldwide, even though it is highly treatable. In 2022, over 3M cases were diagnosed, resulting in 670K deaths globally. According to WHO statistics, it was the most common cancer among women in 157/185 countries. This is largely due to (1) the low sensitivity of current screening technologies, which miss 1 in 3 cases, and (2) high false positive rates (99%), leading to over-diagnosis and inefficient use of healthcare resources. Women with dense breasts who make up 50% of the screening population are particularly affected, as imaging techniques particularly underperform for them, which strains healthcare systems, failing to prioritise those who need care the most. Mammography-based BC screening programs are implemented in 35% of countries worldwide, covering 50% of the global female population. These programs aim to screen asymptomatic women and identify potential BCs. No other cancer screening receives such financial investment. Although millions are spent yearly (€6B in Europe, €220M in DE, €4.8M in ES, €211M in FR, £700M in the UK), there are structural limitations: For every 3 women with BC that enter the screening program, 1 is wrongfully sent home (false negative). On another hand, 99% of recalls are healthy, wasting resources on those who don’t need it.

The Blue Box is an affordable, easy-to-use, cancer screening device using a urine sample. Any healthcare professional can operate it during patient exams, obtaining results in just 30 minutes. The Blue Box improves BC detection sensitivity from 73.0% (normal breasts) or 57.5% (dense breasts) to 88.42%, and reduces false positives with binary easy-to-interpret results, prioritizing patient comfort with a non-invasive, radiation-free approach. It aligns with WHO recommendations for better screening and fits seamlessly into existing screening workflows. Some urine biomarkers have very low molecular weight, making them volatile when heated. They’re called Volatile Organic Compounds (VOCs). Our device specifically targets BC biomarkers that are also VOCs. Like a GC-MS, which characterises a sample's composition according to mass/charge and volatility, our device characterises urine composition according to: (1) each targeted biomarker has a different evaporation temperature; (2) each biomarker can only activate certain sensors. Therefore, The Blue Box outputs a 2D activation map informative about the quantity of activation of each sensor at each temperature. This is the urine’s VOC biomarker signature. Next, our AI algorithm will recognize BC-specific patterns in it.

Women face significant barriers to effective breast cancer detection especially those with dense breasts, for which mammography frequently misses tumours, 50% of women worldwide have dense breast tissue which translates into helping more than 25M of women in the screening age. High costs, invasive procedures, slow diagnoses, and limited access to advanced medical technology, our solution directly addresses these gaps by offering: Affordability – At just €534 compared to €40,000 for traditional methods, our technology makes high-quality breast cancer screening accessible to more women, particularly in low-resource settings. Non-Invasiveness – Our approach is completely pain-free and radiation-free, eliminating discomfort and risks associated with mammography. Many women skip their screening appointment due to this concern. Speed – Rapid diagnostics allow for earlier detection and intervention, improving treatment options and patient outcomes. Higher Sensitivity – Our solution outperforms current market alternatives, particularly for women with dense breast tissue, reducing the likelihood of missed diagnoses. Portability & Accessibility – Weighing only 600 grams and requiring just a power source and WiFi connection, our device can be deployed anywhere, bringing advanced screening to underserved communities without access to traditional imaging technologies.It can be easily integrated into current healthcare workflows.