Check-Cap, a clinical-stage medical diagnostics company, has entered into an agreement with GE Healthcare. The agreement is to develop and validate high-volume manufacturing for X-ray source production and assembly for Check-Cap’s ingestible capsule for colorectal cancer screening.
If all goes well, a collaboration for high-volume manufacturing as well as the distribution of the Check-Cap system is on the table. Check-Cap is conducting a multi-center clinical feasibility study and hopes to file for a CE Mark in the first half of 2017.
Bill Densel, CEO of Check-Cap, explained that GE Healthcare is a leader when it comes to development, manufacturing and distribution of products such as the Check-Cap system. “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,” he said in a statement.
Check-Cap noted that nearly a third of the recommended adult population has never been screened for colorectal cancer or precancerous polyps. The Check-Cap system is meant to improve patient experience while eliminating some issues with current screening measures, such as bowel preparation, invasive procedure and stool handling. Those issues could also pose a barrier to test completion.
The capsule can be ingested and left to do its work as the patient goes about his or her normal day. The patient needs to take a small amount of standard contrast agent with meals.
The low-dose X-ray Radar device creates 2-D and 3-D images of the colon, using 360-degree angular scans that “see through” intestinal content. That means there is no need to clean out the bowels.
The capsule emits radiation equivalent to that of a standard chest X-ray. The information from the capsule is transmitted to a device on the patient’s back. The data is later analyzed by a physician. If nothing is detected, the patient does not require a standard colonoscopy. However, if the Check-Cap device does reveal polyps, a therapeutic colonoscopy would be prescribed.
- here's the press release
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