GE Healthcare has inked a manufacturing development deal with Israel-based Check-Cap.
GE Healthcare will help Isfiya, Israel-based Check-Cap develop and validate high-volume manufacturing around it's ingestible imaging capsule that uses ultra-low dose x-ray and wireless communication technologies to provide colon cancer screening.
The strategic partnership, announced Thursday, involves GE helping with x-ray source production and assembly. It includes potential collaboration on a high-volume manufacturing facility and distribution after the initial partnership is complete.
"GE Healthcare is a global leader in the development, manufacturing, and distribution of diagnostic imaging agents and radio-pharmaceutical drugs and devices," Check-Cap CEO Bill Densel said in a news release.
"We believe that leveraging their experience and expertise provides us with a significant opportunity to meet our goal of increasing the time and cost efficiencies of production of our capsule for use in future clinical trials and commercialization," Densel said.
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Check-Cap is in the midst of a multi-center clinical feasibility study for its imaging capsule and system, and plans to file for a CE Mark within a year.
The Check-Cap system includes a capsule, receiver, and proprietary imaging software. There is also an associated database for access and analysis via the Web.
The system is able to scan the inside of the colon as the swallowed capsule moves through naturally, allowing the people undergoing cancer screening to go about their daily routines. The Check-Cap system generates a 3-D map of the inner surface of the colon, enabling detection of polyps and cancer.
The Check-Cap system seeks to cash in on what the company describes as a fast-growing $25 billion colon cancer screening market involving 35 million patients a year.
Colorectal cancer is the second leading cause of cancer death in the U.S. alone, but nearly one third of people who should be getting the screening don't because they are leery of the bowel preparation, invasive procedure, and stool handling involved in the present testing procedures.
Check-Cap isn't the only company with a pill-based system. Medtronic has its FDA-cleared PillCam that includes a small camera providing views inside the colon. The device, however, is only cleared for patients with major risks for colonoscopy or moderate sedation, though the group indicated to use the device includes people who could tolerate a follow-up colonoscopy should the PillCam detect something abnormal.
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[Image courtesy of Check-Cap]