You can take a pregnancy test or colon cancer test from your bathroom, or, these days, a COVID-19 test from the comfort of your living room. You might one day be able to get a breast cancer screening at home, too, if you have a urine sample and an artificial nose.
That’s the vision behind The Blue Box, a startup competing this week at TechCrunch Disrupt’s Startup Battlefield. The company, founded by Judit Giró Benet while pursuing her Master’s at the University of California Irvine, is developing an at-home handheld device designed to screen urine samples for breast cancer.
The company, founded in January of this year, is in the process of scientifically validating The Blue Box -- which includes both hardware and artificial intelligence components. The Blue Box has been awarded equity-free prizes from Argal (€2,000), the 2020 James Dyson Prize (£35,000), a grant from the Tarragona region of Catalonia (€4,000) and a prize for winning the pitch.tech competition ($10,000).
Benet imagines a product where you might be able to slip a urine sample into an $80 box, have your sample analyzed by a machine learning algorithm (that algorithm is being trained right now) and have test results sent to your phone in about 30 minutes.
“You would have a Blue Box at home and the whole family could use it at home with the frequency your doctor tells you [to],” Benet tells TechCrunch.
Benet says the device is modeled after a series of studies showing that dogs are able to pick up distinctly cancerous smells.
For instance, early-stage studies have shown that specially trained Labrador Retrievers can accurately identify early-stage colon cancer in both breath and stool samples. Urine, the particular bodily fluid of interest to The Blue Box, also has proved to be useful for cancer-sniffing dogs. In one study, German Shepherds were able to identify prostate cancer patients by sniffing out “volatile organic compounds” present in urine samples.
One June 2021 trial on 40 breast cancer patients, 142 patients with non-breast malignant disease and 18 healthy people found that a trained Labrador Retriever could accurately identify the breast cancer patients’ urine samples 40 out of 40 times in double blind-tests. The authors concluded that a screening method based on detecting compounds in urine warranted further study.
The Blue Box is designed to help sniff out breast cancer, sans the dog component.
You might think of The Blue Box itself as a replacement for the dog, and the AI component as a digital brain.
The key for The Blue Box will be clinically validating both parts of the equation. Benet declined to share the specific cancer biomarkers for which The Blue Box will test urine samples -- though she noted that they are pulled from scientific literature.
So far, Benet says, The Blue Box has a minimum viable hardware product that’s “fully functional.”
The next piece of the puzzle is training the machine learning algorithm to recognize late-stage breast cancer. So far, the company reports a 95% classification rate for their algorithm on metastatic breast cancer (a very late stage) -- which means it can accurately categorize 95% of those samples.
That's a first step for the company, but the goal is to be able to detect cancer before it reaches that especially dangerous stage. On that front, The Blue Box is still in the throes of clinical validation. The Blue Box, she says, is currently being studied at University Hospital Joan XXII in Tarragona, Catalonia, and University Hospital Sant Joan in Reus, Catalonia, in a study led out of the University of California, Irvine. So far, they've collected more than 40 urine samples.
Should The Blue Box be able to prove that their technology can accurately detect early-stage breast cancer, there’s evidence that at-home cancer screening tests can gain regulatory approval.
In 2014, the FDA granted premarket approval to Cologuard, a prescription stool test that is designed to detect colon cancer in average-risk individuals. For many screening tests, the critical measure of success is sensitivity or the ability of the test to accurately detect a disease when it is present -- the sensitivity of Colorguard for the detection of colon cancer was 92.3%, per a study in the New England Journal of Medicine.
To follow in those footsteps The Blue Box would also need to have rigorous clinical data to earn pre-market approval and will have to demonstrate high sensitivity.
The Blue Box is also technically a medical device that delivers oncology-related information, which means it will need to work with the FDA to demonstrate its validity before going to market.
“We are a medical device so we will need to go through the FDA and the MDR [the European equivalent of the FDA]. We will start this phase by 2023,” she says.
One of the many arguments made in favor of at-home cancer testing is that it could help close a screening gap.
In the context of colon cancer, fear, whether over the procedure itself or the result, have consistently been identified as barriers to testing in studies, but other barriers -- cost, lack of insurance or transportation, or skepticism about screening guidelines -- also remain powerful.
Breast cancer screenings, argues Benet, face some of the same barriers that colonoscopies do. There is room for improvement in terms of screening. In 2019, 76.4% of women in the U.S. aged 50 and over had gotten a mammogram in the last two years. This number has remained relatively stable since 1998, per the National Cancer Institute, though the pandemic also resulted in a spike in missed screenings that will likely affect more recent statistics.
A 2014 study on underserved women found that the largest barriers to obtaining mammograms was fear of cost (even if the service was free, the fear persists), mammogram-related pain, and the fear of receiving bad news.
The Blue Box, perhaps like Cologuard, seems poised to tackle fears of mammogram-related pain (urine samples are painless). Benet has also thought about the process of receiving the bad news her product might deliver.
Benet says the company is working on incorporating a “virtual doctor” within The Blue Box app that can communicate with a user once they’ve received a diagnosis. “We will try to train this bot so that it can sense the mental state of the patient,” says Benet. “If she's processing the news correctly, if she needs help from a medical professional.”
That feature, she says, should be unveiled in the next few months.
At-home testing isn’t a universal salve to the multifaceted reasons people don’t get cancer screenings. But there is evidence that these at-home tests do reach people who might otherwise forgo a screening.
At-home screening tests, for instance, have allowed healthcare systems to mail out tests to people who might otherwise miss an appointment. A 2018 review paper found that when people received colon cancer tests by mail, colon cancer screenings went up about 22%.
The Blue Box is still in its early validation phase, but if the company can make a similar dent in the breast cancer screening world, Benet hopes it will lead to more people catching breast cancer during early, critical stages.
“I believe that with The Blue Box we will be able to finally create a change that should have happened many, many years ago,” she says.