Although colorectal cancer (CRC) is highly treatable if caught in the early stages, it is the third deadliest form of cancer. Approximately 880,000 people die of CRC and related complications worldwide every year. Regrettably, many patients do not undergo preventative screening for the detection of polyps before they turn into cancer, largely due to the invasiveness of procedures or required bowel preparation. Check-Cap’s C-Scan^®, the first prep-free scanning capsule-based system for the detection of precancerous polyps in the colon, was created to lift the barriers to screening and allow people to stay away from this devastating disease.

The Unmet Need in Colorectal Cancer Screening

In 2005, Dr. Yoav Kimchy founded Check-Cap. Dr. Kimchy started looking for potential solutions to the problem of colon cancer screening after failing to persuade his father, who was at high risk of developing the disease, to have a colonoscopy for colon cancer screening.

The imaging-based tests available at the time included sigmoidoscopy, optical colonoscopy, and computed tomography (CT) colonography. Dr. Kimchy soon began to understand the many barriers preventing patients from taking the tests, such as the invasiveness of the procedures and sedation, pain, and embarrassment, as well as the required bowel preparation, which involves extensive diet restriction, fasting, or laxatives. Insufficient bowel preparation can hinder optimal visibility, which affects the test’s accuracy and disrupts the normal operation of the procedure. Dr. Kimchy’s goal was to develop a solution that adapted the procedure to the patient, instead of adapting the patient to the procedure. He believed that a more patient-friendly prep-free preventative screening test would increase screening adherence rates and save lives. This realization led him to develop C-Scan, Check-Cap’s key technology, a CRC screening device delivered in the form of an ingestible capsule. Unlike tedious, embarrassing procedures like colonoscopies, C-Scan enables prep-free screening while patients continue their daily routines.

Other patient-friendly, non-invasive, CRC screening tests have been developed during the last decade, which leverage blood and stool samples in search of cancer biomarkers. While those tests can help with early cancer detection, they are not preventative, and they are only sensitive at detecting cancer. But, why wait for cancer? Check-Cap’s goal is to provide patients with a patient-friendly alternative that can detect structural abnormalities before they turn into cancer

The Breakthroughs Behind C-Scan Technology

The C-Scan System utilizes an ultra-low dose  of an X-ray emitting capsule, an integrated positioning, control, and recording system, as well as proprietary software to generate 2D and 3D maps of the inner lining of the colon. What is unique about this technology is that unlike other X-ray diagnostics systems, the C-Scan capsule – C-Scan Cap^® contains the X-ray emitter and the X-ray detector on the same surface. The system relies on two distinct physical phenomena that occur between X-ray photons, the contents of the colon, and the colon’s epithelium. The first, X-ray fluorescence, occurs when X-ray photons emitted by the capsule and ingested contrast agent interact to produce secondary X-ray photons, some of which are back-scattered, recognized, and recorded by X-ray detectors in the capsule. The X-ray photons emitted by C-Scan also go through Compton scattering, a process in which they interact with the electrons of atoms in the colon wall and lumen. When these photons bounce back, the capsule measures and records their flux. These two processes allow the system to calculate the distance between the capsule and the colon wall, for the detection of structural abnormalities, such as colorectal polyps.

The C-scan uses ultra-low dose radiation, hundreds of times lower than conventional X-ray imaging techniques, mammography screening, or abdominal CT scans. Such a low dose is possible because the C-Scan capsule is in such close proximity to its scanning targets. Additionally, the X-ray source and X-ray detectors within the capsule are sensitive enough to count single photons. The source emits three beams to scan the colon as the capsule moves through the digestive tract. The X-ray source emission is only powered while the capsule moves through the colon.

The capsule's processing unit collects the data acquired during passage through the colon and transmits it through radiofrequency communication to the C-Scan Track, an external wearable tracking system. The gastrointestinal tract’s natural motility moves the capsule on its course, and the patient can go about their day normally.

The only action required of the patient is to begin the screening process by swallowing the capsule with a small amount of radiopaque contrast solution along with a tablespoon of fiber. Patients will excrete the capsule naturally after the scan is completed, and it does not need to be retrieved, since all the data is communicated from the capsule to the tracking device throughout the test. The track then notifies the patient that the test is finished.

After the test has completed, technicians can download the data from the C-Scan Track to the C-Scan View workstation for review and analysis to be finally signed off by a physician.

Using Check-Cap’s proprietary software, physicians can use C-Scan View to create 2D and 3D models of the interior surfaces of the patient’s colon. In the 2D view, physicians can locate and examine abnormalities that suggest possible masses or polyps. C-Scan View’s 3D “Fillet” mode allows for closer inspection of the colon’s surface features. The 3D “Tube” mode offers a three-dimensional outer view of a colon segment as seen by the capsule, and, in 3D “Fly” mode, the model follows the journey taken by the capsule, creating a view from the perspective of the capsule itself.

The Potential of C-Scan

The impact of our technology is clear. By providing a prep-free, patient-friendly option, the technology has the potential to increase screening adherence. When more patients undergo preventive cancer screenings following suggested timelines, there is a greater chance of cancer prevention by detecting abnormalities before they turn into cancer, as well as detecting cancer early enough, when treatment options are more effective.

Colorectal cancer is the third most common form of cancer and is highly preventable. We hope we can soon offer this technology to as many patients as possible. Our vision is to see our products used all over the world to contribute to reducing CRC incidence worldwide.