Check-Cap Ltd., a medical diagnostics company based in Israel, has entered into an agreement with GE Healthcare to develop high-volume manufacturing of an x-ray source for Check-Cap’s ingestible capsule for colorectal cancer screening. The investigational system uses ultra–low-dose x-ray and wireless communication technologies to scan the inside of the colon while patients follow their daily routines. After passage, the system generates a 3-D map of the inner surface of the colon, which allows clinicians to detect polyps and cancer.
Check-Cap is conducting a clinical feasibility study and plans to file for a CE mark, which certifies that a product has met European Union health, safety, and environmental requirements, in the first half of 2017. The system is not available for sale or for any clinical use.
Colorectal cancer is the second leading cause of cancer death in the United States, with an estimated 134,000 diagnoses and 49,000 deaths in 2016. Despite evidence that screening can detect colorectal cancer and precancerous polyps, nearly one-third of the recommended adult population has never been screened, according to Check-Cap.
Optical colonoscopy is currently the standard screening tool for early detection of colon cancer, demonstrating a high degree (approximately 95%) of sensitivity and specificity. However, compliance remains an issue. Many patients avoid screening because of colonoscopy’s invasiveness, discomfort, and perceived risks, with bowel preparation being a significant drawback.
Check-Cap’s imaging capsule contains a device that transmits x-rays, with minimal radiation, to the intestinal wall and back. Once the capsule has been prescribed by a physician, the patient will drink a small amount of a radio-opaque contrast agent (such as barium sulfate or iodine) in the doctor's office as he or she swallows the capsule. The patient will then drink the same amount of contrast agent with meals during the remainder of the screening while continuing with his or her normal routine. Bowel cleansing is unnecessary since x-ray technology, unlike optics, creates 360-degree angular scans that can “see through” intestinal content.
The capsule is propelled through the intestinal tract through normal motility, and although it will be naturally excreted, it does not need to be retrieved for data collection. The data gathered within the colon are transmitted to a receiving device worn on the patient’s body that stores the information for offline analysis. The receiver also indicates when the capsule has been excreted (within approximately 24 to 48 hours of the beginning of the screening).
After the data have been collected from the receiver, a physician will use a data-viewer software application to determine whether anatomical anomalies are present on the surface of the colon. The analysis of distances creates 3-D images of the colon’s internal surface, enabling the detection of clinically significant polyps with a high degree of sensitivity, according to Check-Cap.