The Blue Box

1 in 8 women will have breast cancer (BC) at least once, with it being the most commonly diagnosed cancer among women worldwide. Shockingly, although BC is one of the most treatable cancers, it is the most deadly cancer in women. The main reason for this is not a lack of treatment options but rather a lack of accessibility to an early-stage diagnosis. Indeed, mammography does not provide clear visualization of small tumors in young women, who have dense breast tissue, and 44% of tumors are overlooked. Hence, most healthcare systems only invite women aged 50-69 to mammogram-based screenings, but 27% of BCs will happen to young women outside the screening age.

Many countries, including Brazil and Norway, have reported an increase in incidence of BC in women under 50 years of age.  The American Cancer Society estimated the risks for invasive BC to be 4% for women <40 years, though the number could likely be higher due to limited screening of this population. The incidence for women between ages 40-49 is estimated to be 13%.

The Blue Box® is a point-of-care in-vitro diagnostics medical device for breast cancer testing. For young women (<50), our technology is more sensitive (88.33% vs 56.10%) and accurate (83.32% vs 70.40%) than mammography. Namely, 30% less breast cancers would be left undiagnosed with The Blue Box®.

The Blue Box® contains 9 chemical sensors that are sensitive to a set of BC biomarkers, some of which are small enough to evaporate when urine is heated up. When they do, they fill our device’s inner headspace (i.e., the confined air volume between the sample and the sensors), and continuously activate our sensors as their headspace concentrations increase. This activation is what we call “urine’s fingerprint”, and characterizes the composition of urine in 2 dimensions: (i) each biomarker activates each of our sensors differently and (ii) each biomarker volatilisation is specific to a narrow temperature range.

In the particular case of Spain: From all 24M Spanish women only 5.3M, (20%) take a mammogram biannually. Of all 19M women who do not get tested, 92% want to (according to our customer discovery interviews), but do

not have access to it. In the Spanish Healthcare only women >50 are invited to get tested. 

We will provide all these women left aside from the system with access to diagnosis every year, so If they need treatment It is going to be detected soon enough not to be as dangerous as It would be in late-stages.

It is radiation-free, pain-free and low-cost, our mission to democratize access to breast cancer early detection.

We are a mainly tech/science-focused team.

- Judit Giró Benet, CEO & co-founder, is a Catalan biomedical engineer who gained global recognition in 2020 for inventing The Blue Box, a device tailored to address the critical gap in breast cancer screening for women aged 20-49. Recognizing that this demographic lacks reliable screening methods despite accounting for ⅓ of breast cancer cases, Judit innovatively developed a radiation-free, pain-free, and cost-effective solution. The Blue Box boasts an impressive sensitivity of 88.33%, outperforming mammography by over 30% for this specific age group.

Transitioning to entrepreneurship, Giró co-founded The Blue Box Biomedical Solutions, successfully securing partnerships with 7 hospitals. The startup's innovative approach attracted €1.5 million in funding, driving its mission to democratize access to breast cancer early detection. By 2025, The Blue Box aims to introduce this transformative solution in gynecology clinics through a software-driven business model, propelling its mission to democratize access to breast cancer early detection. 

- Joan, CTO, co-founded an (EIC Accelerator-awarded) startup and led the development of its medical device through R&D, production, and regulatory affairs.

- Lidia, COO, worked on H2020 projects and as an independent expert evaluator for the EC. She has a master’s in Administration and Business Management.

- Júlia, CSO, has a PhD consisting of developing R packages to process eNose-acquired data from urine samples to detect cancer using machine learning.

Pilot Test 1: Ability to detect advanced breast cancer

We started building the first prototype of The Blue Box at the University of Barcelona in 2018. This first prototype cost 35€. To test it, 90 human urine samples were collected from control subjects and advanced breast cancer patients at Sant Joan University Hospital in Reus, Spain. In 2021, class prediction was achieved with a sensitivity of 75% (nature.com/articles/s41598-022-17795-8)

Pilot Test 2: Ability to detect early-stage breast cancer

During July 2021-March 2023, we trained our bioinformatics algorithm for early-stage breast cancer by running 7 pilots at7 hospitals: University Hospital La Paz in Madrid (ranked among the 100 best in the world),Dexeus Mujer UH in Barcelona, UH Joan XXIII in Tarragona, Sant Joan de Reus UH, Valls Pius H., Consorci Sanitari de Terrassa and Infanta Sofía H. 

In March 2023, we obtained scientific results demonstrating we had surpassed our target of mammography equivalence. We then shifted our focus from R+D to Industrialization. Thanks to these good results, we have been selected to present a poster with our results at the “Congreso Español de la Mama” (Spanish BC Congress), in Madrid on Oct, 2023 and the San Antonio Breast Cancer Symposium, in Texas on Dec 2023.

In 2024 we will be preparing to launch in our first market: EU. Our goal is to first analyse which markets can adopt our solution faster and adapt our business model to each of those. For this, we would need technical support. We will first launch at Spain, Germany and an additional EU state. We want SOLVE to help us identify the right partners to do so: distributors, hospitals that can be early adopters, as well as understanding the client, the need for reimbursement... 

For 2025, we plan to go after the FDA approval and we will need to face cultural and market barriers for that different area.

Science has long demonstrated the feasibility of detecting BC in urine, but there is no standalone urine biomarker that is univocally indicative of BC. The Blue box can diagnose BC based on the presence of a set of biomarkers and the proportionality between their intensities. In other words, we are using bioinformatics to recognise a pattern within a patient’s biomarker fingerprint that is indicative of BC. This is our trade secret.

Body fluids are typically analyzed with GC-MS (Gas Chromatography-Mass Spectrometry), but such a method is unsuitable for screening: It is expensive and requires rained personnel and expensive facilities. By adding a substantial layer of data pre-processing, we can acquire high-quality data with a low-cost, easy-to-use, point-of-care device that is fast, accessible, radiation-free and comfortable. This is protected by our patent.

The proposed solution is designed to help women, a social group typically underrepresented in medical technology and research, live a full life without the fear and anxiety caused by the currently offered breast cancer screening programs.

Although Breast Cancer is one of the most treatable cancers, it is the most deadly cancer in women. We will a have a positive impact in proving women an early-stage diagnosis. For this demographic, who are often left aside from regular scans / follow-ups, we will provide a technology more sensitive and accurate than the mammogram.

We will provide women aged 20-49 with a reliable, accessible, radiation-free, pain-free, low-cost and easy-to-operate device to detect breast cancer in urine, so that they can be breast cancer diagnosed in time. The Blue Box contains 9 chemical sensors that are sensitive to a set of BC biomarkers, some of which are small enough to evaporate when urine is heated up. When they do, they fill our device’s inner headspace (i.e., the confined air volume between the sample and the sensors), and continuously activate our sensors as their headspace concentrations increase. This activation is what we call “urine’s fingerprint”, and characterizes the composition of urine in 2 dimensions: (i) each biomarker activates each of our sensors differently and (ii) each biomarker volatilisation is specific to a narrow temperature range.

Judit Giró co-founder & CEO. Biomedical engineer, gained global recognition in ’20 for inventing The Blue Box.
Lidia Navarro PhD, COO. Building Engineer who worked as an independent expert evaluator for the EU Commission under Horizon Europe programme (’22). She now brings in her ability to translate an overarching goal into work packages, tasks, deliverables and key results, thus optimizing the team and funds.
Joan Vieyra CTO. Biomedical Engineer. 2 mSC. He has worked in an in-vitro diagnostics startup and previously founded a startup, he brought a medical device for sepsis detection from a concept stage to medical device regulations stage.

Judit Giró: +5 years

Joan Vieyra: +3 years

Lidia Navarro: + 2 years

Silvia, Arnau y Andrea: months

We foster diversity, equity, and inclusion within our team in different ways:

1. Diversity: We celebrate diversity in all its forms, including race, ethnicity, gender identity, sexual orientation, age, ability, religion, socioeconomic background, and more. We understand that diverse perspectives drive innovation and creativity, which are essential in the highly dynamic field of medical technology. In our company we are people from Catalonia and Latin America. We are women and men working along.
2. Inclusion: we put our efforts so everyone feels a sense of belonging and are empowered to bring their authentic selves to work. We promote open communication, collaboration, and mutual respect among team members. Once a month, we do a team-building activity to know each other better. We actively seek out and amplify women voices that have historically been marginalized or underrepresented in our industry. 
3. Equity: We are committed to ensuring equity within our organization by providing equal access to opportunities for all team members. We strive to create a level playing field where everyone has the chance to thrive and succeed based on their merit and contributions.

We will have two revenue streams:

We'll charge clinics a monthly subscription to rent our HW.

We’ll distribute our product as a SaaS (Software as a Service): We’ll charge a fee per SW run, i.e. per each BC test

Total sources of funding for The Blue Box to date:

Since its foundation, The Blue Box has won several international awards and recognitions, including the James Dyson Award 2020 and the 1st place at the US-wide pitch.tech competition by Startup Grind, and being within the 20 finalists of TechCrunch Disrupt Battlefield 2021. The Blue Box has received public funding from the European Commission and been part of several incubators and accelerators, including: Wayfinder (UC Irvine), SkyDeck HotDesk (UC Berkeley), Global Grad Show (Arm Dubai Group), MassChallenge Boston, and CIMTI (incubator promoted by Catalan Department of Health).