The Blue Box and At-Home Breast Cancer Tests - A Future Outlook

Revolutionizing Cancer Detection: The Blue Box and At-Home Screening

Advances in medical technology are bringing diagnostic capabilities directly to individuals. From pregnancy tests to COVID-19 assessments, healthcare is increasingly accessible within the home. Now, a startup called The Blue Box envisions a future where breast cancer screening can also be performed conveniently, utilizing a simple urine sample and an innovative artificial nose.

Introducing The Blue Box: A Novel Approach to Breast Cancer Screening

The Blue Box, currently competing at TechCrunch Disrupt’s Startup Battlefield, is developing a handheld device for at-home breast cancer screening. Founded by Judit Giró Benet during her Master’s studies at the University of California Irvine, the company aims to provide a non-invasive and accessible method for early detection.

Established in January of this year, The Blue Box is actively undergoing scientific validation, encompassing both hardware and artificial intelligence components. The company has already secured several equity-free prizes, including awards from Argal (€2,000), the 2020 James Dyson Prize (£35,000), a grant from the Tarragona region of Catalonia (€4,000), and a prize from pitch.tech ($10,000).

How The Blue Box Works: Mimicking Canine Detection

Benet envisions a user-friendly product where a urine sample is analyzed by a machine learning algorithm, with results delivered to a smartphone within approximately 30 minutes. The cost of the device is projected to be around $80.

“A Blue Box could be a household staple, utilized by the entire family as frequently as their doctor recommends,” explains Benet to TechCrunch.

The device’s functionality is inspired by research demonstrating the remarkable ability of dogs to detect cancer through scent. Studies have shown that trained canines can accurately identify early-stage colon cancer in breath and stool samples.

Scientific Basis: The Power of a Canine Nose

Urine, specifically, has proven valuable in cancer detection for dogs. For example, a study revealed that German Shepherds could identify prostate cancer patients by detecting “volatile organic compounds” in urine.

A June 2021 trial involving 40 breast cancer patients, 142 patients with other malignant diseases, and 18 healthy individuals demonstrated that a trained Labrador Retriever accurately identified breast cancer patients’ urine samples in all 40 double-blind tests. The researchers concluded that urine-based cancer screening warrants further investigation.

The Blue Box: An AI-Powered Alternative

The Blue Box aims to replicate the canine detection process without the need for a dog. The device itself functions as a substitute for the dog, while the AI component serves as a digital brain.

A crucial step for The Blue Box is the clinical validation of both its hardware and software. Benet has chosen not to disclose the specific cancer biomarkers the device will analyze, but confirms they are derived from existing scientific literature.

Current Progress and Future Goals

Currently, The Blue Box possesses a fully functional minimum viable hardware product. The company is now focused on training its machine learning algorithm to recognize late-stage breast cancer.

Initial results are promising, with the algorithm achieving a 95% classification rate for metastatic breast cancer samples. However, the ultimate goal is to detect cancer at earlier, less dangerous stages. Clinical validation for early-stage detection is currently underway at University Hospital Joan XXII in Tarragona, Catalonia, and University Hospital Sant Joan in Reus, Catalonia, in collaboration with the University of California, Irvine, with over 40 urine samples already collected.

Regulatory Pathway and Potential for Approval

If The Blue Box can demonstrate accurate early-stage breast cancer detection, it could potentially gain regulatory approval, mirroring the success of Cologuard, an FDA-approved at-home stool test for colon cancer.

Cologuard boasts a sensitivity of 92.3% for colon cancer detection, as reported in the New England Journal of Medicine. The Blue Box will need to demonstrate comparable rigorous clinical data and high sensitivity to secure pre-market approval.

As a medical device delivering oncology-related information, The Blue Box will collaborate with the FDA and the MDR (European equivalent of the FDA) to validate its technology before market launch, with this phase anticipated to begin in 2023.

Addressing the Screening Gap

At-home cancer testing has the potential to address barriers to screening, such as fear of the procedure or results, cost, lack of access to transportation, and skepticism regarding screening guidelines.

Improving Access and Addressing Patient Concerns

Studies have consistently identified fear as a significant deterrent to colon cancer screening. Breast cancer screenings also face similar challenges. In 2019, 76.4% of women in the U.S. aged 50 and over had received a mammogram within the past two years, a figure that has remained relatively stable since 1998, according to the National Cancer Institute. However, the pandemic caused a noticeable increase in missed screenings.

A 2014 study on underserved women revealed that fear of cost (even when services are free), pain associated with mammograms, and fear of receiving a positive diagnosis were major obstacles to obtaining mammograms.

Integrating Support and Technology

The Blue Box aims to alleviate the fear of mammogram-related pain by utilizing a painless urine sample collection method. Benet is also developing a “virtual doctor” within the accompanying app to provide support and guidance following a diagnosis.

“We are working to train this bot to assess the patient’s mental state,” explains Benet. “To determine if they are processing the news appropriately and whether they require assistance from a medical professional.” This feature is expected to be available in the coming months.

The Future of At-Home Cancer Screening

While at-home testing isn’t a panacea for all the reasons people avoid cancer screenings, it has proven effective in reaching individuals who might otherwise forgo testing. A 2018 review paper found that mailing colon cancer tests increased screening rates by approximately 22%.

The Blue Box is currently in the early stages of validation, but if successful, Benet believes it could significantly improve early breast cancer detection rates. “I believe that with The Blue Box, we will be able to finally create a change that should have happened many years ago,” she concludes.