Check-Cap, a clinical stage medical diagnostics company engaged in the development of an ingestible capsule for preparation-free, colorectal cancer screening, has entered into an agreement with GE Healthcare to develop and validate high-volume manufacturing for X-ray source production and assembly into Check-Cap’s capsule.

The capsule utilizes ultra-low dose X-ray and wireless communication technologies to scan the inside of the colon as it moves naturally, while the patient follows his or her normal daily routine.  After passage, the system generates a 3-D map of the inner surface of the colon, which enables detection of polyps and cancer.  

Designed to increase the willingness of individuals to participate in recommended colorectal cancer screening, the Check-Cap system addresses many frequently-cited barriers, including laxative bowel preparation, invasiveness, and sedation.

Upon successful completion, the parties may discuss collaboration on execution of a high-volume manufacturing facility and distribution of the Check-Cap system.

“We are very excited to commence this strategic relationship with GE Healthcare as we continue our efforts to optimize the supply chain for the Check-Cap system,” said Bill Densel, CEO of Check-Cap.

Colorectal cancer is the second leading cause of cancer death in the U.S., with an estimated 134,000 diagnoses and 49,000 deaths in 2016.  Despite compelling evidence that screening can detect colorectal cancer and precancerous polyps, nearly one-third of the recommended adult population has never been screened. 

Check-Cap is currently conducting a multi-center clinical feasibility study and expects to file a CE Mark submission for the Check-Cap system in the first half of 2017.