The Blue Box, the device to detect breast cancer with a urine test

Las cofundadoras de The Blue Box, Lidia Navarro y Judit Giró

The company is preparing to begin clinical trials in Europe, with the goal of obtaining CE marking in 2026

22 august of 2025 at 17:26h

When Judit Giró was studying biomedical engineering at the University of Barcelona (UB) in 2019, a question began to nag at her: why does breast cancer detection still depend on technology that has barely changed since the 1960s? That reflection became the spark that ignited The Blue Box, the biomedical startup she now leads with her co-founder, Lidia Navarro, and which aims to facilitate early detection of breast cancer with a device as simple to use as a pregnancy test.

The story of The Blue Box begins with Giró's astonishment at dogs' ability to detect cancer through smell. Trained, they can detect the volatile compounds of the disease through the smell of sweat or urine. At this point, Giró considered bringing this ability to a device that would allow early detection of breast cancer with a simple urine test. The sample simply needs to be placed inside the device ---which looks like a compact blue box--- and wait for the result.

From that idea came a first rudimentary prototype, built manually, which soon began to yield promising results, in collaboration with a hospital. From there, the project grew, becoming a company that today has a team of ten people, based in Barcelona and the United States, and more than 4.6 million euros raised in funding rounds.

What started practically as a home experiment has become a high-tech medical device. "We went from that first artisanal prototype to an industrialized device with its own artificial intelligence algorithm," explains Giró. The advance has not only been in engineering: The Blue Box is now preparing for a decisive milestone in 2025, when clinical trials will begin in Europe. The next step will be to obtain CE marking in 2026, which will open the doors to the market.

Of the 4.6 million it has raised so far, the company recently secured 3 million, which will allow it to advance in clinical validation. To detect breast cancer, the device integrates a system of chemical sensors that identify altered patterns of volatile compounds. This information travels to an artificial intelligence algorithm that determines if there are signs of cancer. In practice, it is a non-invasive, radiation-free, and easy-to-apply test that can be performed in a gynecological consultation without the need for large equipment or infrastructure.

The great advantage over mammography, according to Giró, lies in its precision in women with dense breasts, a group that represents 50% of the screening-age population and in whom mammography loses effectiveness. "Our ultimate goal is to become the future universal screening standard, although in the first market launch we will start by complementing mammography," she explains.

The Blue Box device.

Although The Blue Box was born between Barcelona and California ---with the sensor technology developed at the UB and artificial intelligence at the University of California, Irvine---, the immediate priority of the startup is in Europe, where they want to clinically validate the tool and obtain CE marking.

But the United States is also in their sights. "We are working on strategic alliances in the United States, where there is a lot of interest in non-invasive screening solutions," says Giró. In the long term, the ambition is clear: to become a global tool, especially useful in countries with less access to advanced diagnostic infrastructures.

The Blue Box team, with Judit Giró in the center.

"We want no woman to fail to detect cancer in time due to fear, discomfort, or lack of access," Giró asserts. Breast cancer remains the most diagnosed cancer in women worldwide, and early detection is still key to increasing survival rates.

Now, The Blue Box's challenge will be twofold: to demonstrate clinical efficacy in real-world scenarios and to prepare the regulatory and commercial path. Obtaining CE marking in 2026 will open the possibility of introducing the test in gynecological consultations, first as a complement to mammography and, later, as a universal standard. With one goal: to revolutionize the way millions of women face breast cancer screening.