Colorectal cancer (CRC) is a killer. In 2017 in the U.S. alone, 52,547 people died and 141,425 new cases were reported, according to the CDC. In 2018, fewer than 70% of U.S. adults aged 50 to 75 years were up to date with colorectal cancer screening. Colorectal cancers usually start as polyps and develop very slowly, typically over a 10-year period. For most adults in the target age range, a colonoscopy every five years is sufficient. Many people avoid colonoscopies because of the required fasting and bowel-cleansing preparation, the invasiveness, and for those without medical insurance, the cost. Personally, I’ve had more than my share of colonoscopies due to a related issue.

Check-Cap, an Israel-based company has developed a prep-free CRC screening technology called C-Scan that consists of three components. The C-Scan Cap is an ingestible capsule. The patient swallows the capsule along with a contrast agent. As it travels through the digestive system, the capsule scans the entire gastrointestinal tract with ultra-low dose X-ray beams as the patient goes about his or her day. Three miniaturized patches called C-Scan Track worn on the patient’s back manage the positioning, control, and continuous recording and storage of the scanned data. Finally, C-Scan View, a PC-based workstation runs a cloud-based analysis suite that constructs 2D and 3D maps of the colon’s inner surface. Check-Cap-trained technicians then analyze the data and bookmark any suspicious areas for physician inspection.

The C-Scan System has CE approval. Following the approval, Check-Cap conducted a post-CE evaluation study that compared C-Scan with a fecal immunochemical test (FIT), another non-invasive test for colorectal cancer. The researchers used colonoscopies to validate the study results. The C-Scan System performed significantly better than the FIT with 76% sensitivity in correctly identifying patients with polyps and 82% specificity in correctly identifying patients with no polyps.

Check-Cap conducted a pilot study in the U.S. from 2019 to 2020 at the New York University School of Medicine and the Mayo Clinic. Check-Cap also plans a pivotal study in the U.S. in 2021 as part of the process to obtain U.S. approval.