Five Questions and an Elevator Pitch: ColoTech

1. What is the need that your project seeks to address?

Kelly: We are looking to increase screening compliance for colorectal cancer, the second leading cause of cancer death among cancers that affect both men and women in the US, according to the Centers for Disease Control and Prevention. The gold standard screening method is colonoscopy, that can reduce the risk of colorectal cancer by almost 80%, as polyps found during the procedure can be removed before they turn into cancer. However, many people delay or avoid the invasive procedure, usually done on an outpatient basis under sedation, due to the unpleasant bowel prep and fear that the procedure will be uncomfortable.

Shreya: Colonoscopy also has low efficacy in detecting early-stage cancers, specifically a precancerous tissue called dysplasia. When colorectal cancer is detected early, the five-year survival rate is 91%. As it progresses to stage four, the five-year survival rate drops to just 15%.

The patient groups we're targeting are those at higher risk of colorectal cancer. This includes those with inflammatory bowel disease, who have highly inflamed gastrointestinal [GI] tracts that tend to yield higher cancer rates and are recommended to have a colonoscopy every one to three years.

Gabe: Our solution allows for a screening mechanism to assess high-risk patients as often as necessary, that can lead to fewer unnecessary and costly colonoscopies. Another goal of our project is to help track disease progression over time in patients who are found to have precancerous tissue. This allows for interventions to be done early, when the chances of survival are much higher.

2. How does your solution work?

Shreya: We are devising a diagnostic tool for the detection of early-stage colorectal cancer, that we expect would lead to higher patient compliance versus gold standard colonoscopy.

Kelly: To make the detection of colorectal cancer less invasive, our approach is to create a pill, which a patient would swallow, that contains a molecular compound that dissolves as it travels through the GI tract. When the compound is in contact with a hypoxic—or low oxygen—environment, which is typical with precancerous or cancerous tissue, a part of the molecule will cleave off. A stool sample would then be examined using a spectrophotometer, a type of equipment that most clinics have for other types of assays that they run as standard practice.

The goal is that the molecule segment that cleaves off will emit a fluorescence signal that can be detected through spectrophotometry. If it fluoresces green, the patient has precancerous tissue or dysplasia present. If it fluoresces red, that means the molecular segment hasn’t cleaved off and dysplastic tissue is not detected. The fluorescence intensity can indicate the degree of dysplasia or cancer. If problematic cells are detected, then the patient would undergo a colonoscopy and further treatment. Our method wouldn’t show where the suspicious cells are in the GI tract, just that they are present or not.

We are hoping that our solution will greatly increase patient compliance versus colonoscopy, so that deadly colorectal cancer can be detected in its earliest stages and lives can be saved.

3. What motivated you to take on the project? And what activities have you undertaken?

Shreya: We started the project in the Senior Bioengineering Capstone course, where we were assigned the need space of colorectal cancer. Through our initial research, we realized that currently there are not a lot of reliable endogenous biomarkers of colorectal cancer, as there are for other types. We were inspired to engineer this prodiagnostic as our own exogenous biomarker mechanism of detection.

Gabe: We've done extensive needs finding and solution exploration by interviewing gastroenterologists, as well as chemistry, imaging, and optics experts about the idea and if it is a worthwhile, marketable pursuit. We've also created our molecule in the lab and are working to ensure that it contains the ideal characteristics for fluorescence. We’ve also done some in vitro lab experiments with colorectal cancer cells.

Shreya: We dedicated many weeks to a proof-of-concept study, where we tested our molecule using LC-MS [liquid chromatography-mass spectrometry] as our detection method. We’re now identifying the final chemistry of our molecule.

All three of us will remain at Stanford for another year, so we'll be able to continue our work, which we're really excited about.

4. What are the most important things you learned in advancing your project?

Shreya: Through the project to date, we’ve been able to rely on each other as teammates and work on each step of the process together—troubleshooting, planning, and ideating. Also, as none of us have a background in chemistry, we were fortunate to find great mentors who could help bridge the gap between where we were and where we wanted to be. Their expertise allowed us to push the project forward.

5. What advice do you have for other aspiring health technology innovators?

Kelly: My advice would be to first dig deep into the need area before you focus on a solution. This includes reaching out to experts, such as doctors who understand your patient population, and then devising your solution from there. Make progress little by little and eventually you'll see your idea come to life.

Gabe: Also, don’t necessarily get tied to a single solution. If you assume there’s only one way to solve a problem, then you’ll miss out on so many opportunities. Staying flexible and being ready to pivot can be so beneficial for finding the optimal path forward.