Colonoscopy is the accepted standard for colorectal cancer screening with the Center for Diseases Control estimating that if people were screened, then 60 percent of the deaths due to this disease could be avoided. 

The problem is that the prepping for the procedure is so intensive and time consuming, and the procedure so invasive - a flexible tube with a video camera is inserted through a person's rectum - that many people simply don't get screened.

DNA tests are being developed but haven't proved their mettle yet. Now Israeli start-up Check-Cap has launched first-in-human clinical trials for its innovative device to perform non-invasive colon imaging. The Check-Cap capsule - about 33 mm in length and 11 mm in diameter - incorporates X-Ray fluorescence technology which when swallowed can take images of the colon from inside the organ and wirelessly transmit that data to a receiver.

The most important feature? Zero prep of the bowel is required, said Guy Neev, Check-Cap's chief executive officer, who was in Minneapolis with Noah Lewis, managing director of GE Ventures' healthymagination fund last week. GE has invested in the company.

"Our idea was to develop a pill that will know how to work in a dirty environment," Neev said. "Rather than amending the patient to the pill, we wanted to develop the pill for the colon which is usually full of content."

The fact that with Check-Cap no bowel preparation is required is significant when contrasted with current prep requirements for colonoscopy. Currently, someone undergoing the procedure needs to be on a liquid diet for one to two days and may need to take laxatives in order to get the bowel clean enough for the colonoscope to be inserted and for the colon to be viewed. That's because detecting a polyp requires the bowel to be absolutely transparent such that the probe can clearly see a growth. Presence of bile and stool obstruct that view. Not only do patients have to endure the prep, they also have to go to take the day off for the procedure and be put on a sedative while the doctor probes their organs.

With Check-Cap, they swallow some contrast agent and the capsule. The contrast tags stool a certain color and the capsule is thereby able to distinguish between stool and tissue and take images. After the images are taken, the capsule passes out of the body naturally.

The data is transmitted to a wireless reader that the patient wears when the capsule is in the body. And that receiver transmits the data to a companion software on the physician-end where the raw data is reconstructed into images, Neev explained.

Best of all, while the colon is being X-rayed by the capsule, the patient can go about their day instead of being sedated and lying on a hospital bed.

Capsule endoscopy is not new, but Neev said that it requires an even more intensive bowel preparation than Check-Cap's capsule. It also requires a trip to the hospital because those capsules have only a certain window of time within which the colon can be imaged before bile starts to penetrate the organ.

Eliminating that trip to the hospital is another reason Neev feels the product will be a winner in the marketplace given the intense focus on cutting costs these days. 

So far the company has raised between around $20 million to $30 million from various investors in Israel and Europe, as well as from GE. Soon the company will launch another fundraising round through which Neev hopes to garner $10 million to $12 million. He appeared confident of a follow-on investment from GE - after all, Lewis was accompanying him on a U.S. road show.

Predictably, however Lewis declined to be comment on whether GE would invest in Check-Cap again. 

The start-up is expecting for CE Mark in 2014, with a market launch in that region in the second half of next year. The U.S. pivotal trial will likely begin in early 2015.

Neev is confident of the capsule's safety and zero side effects.

"I and the founder/CTO of the company swallowed the pill ourselves," Neev declared. 

-- By Arundhati Parmar, Senior Editor, MD+DI

Related Content

X-Ray May Be Alternative to Colonoscopy

Artificial Intelligence Used to Diagnose Colon Tumors