Check-Cap announced on Wednesday that its C-Scan system for colorectal cancer screening scored CE mark.

“[Physicians] are very excited about this because of its uniqueness,” Bill Densel, CEO of Check-Cap, told HCB News. “They realize that 35 percent of Americans don’t get screened for colorectal cancer because of the bowel prep required.”

Colorectal cancer is the third most common cancer worldwide, according to the World Cancer Research Fund International. Evidence shows that removing adenomatous polyps reduces the incidence and mortality of colorectal cancer.

C-Scan is an ingestible, ultra-low dose X-ray capsule combined with wireless tracking system. It obtains structural information that is used to generate 2-D and 3-D maps of the colon, which physicians use to identify precancerous polyps and other abnormalities.

The regulatory approval was based on a study that compared the effectiveness of a fecal immunochemistry test (FIT), which is the primary screening method, and C-Scan. The results showed that 37 percent of polyps were detected with FIT and 44 percent were found with C-Scan.

“We can’t replace colonoscopy because it’s a gold standard and it can remove polyps at the same time,” said Densel. “What we are offering with C-Scan is a chance to look at patients who refuse to get a colonoscopy.”

He added that if a polyp is detected with C-Scan, the patient would then be more inclined to undergo a colonoscopy to have it removed.

Check-Cap announced a manufacturing collaboration with GE Healthcare last month. As part of the deal, GE will assemble, package and ship C-Scan capsules initially to support Check-Cap’s U.S. pilot trial for FDA approval, which is expected to launch this quarter.