Colonoscopy is an effective screening tool to detect polyps in the colon that could be cancerous.

But the problem is that it requires significant prep work on the part of the patient — you have to drink a ton of liquids, clean out the gastrointestinal tract — to get ready for an invasive endoscope to be inserted in the body. People may have to miss a day’s work to properly prep for the procedure. All of this has an impact on how many people actually undergo colorectal screening.

Check-Cap, an Israeli diagnostics company, is developing an ingestible capsule that is able to take X-ray images of the colon as it travels through a person’s body eliminating the elaborate prep needed. The company announced Thursday that it is collaborating with GE Healthcare to “develop and validate high-volume manufacturing for X-ray source production and assembly into Check-Cap’s capsule.”

Check-Cap had another collaboration with GE that was announced in 2012. If the current project is successful, the two companies may enter into an agreement by which GE could help to manufacture and distribute the product.

“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, in a news release.

In a interview that I conducted in 2013 for MD+DI, then CEO Guy Neev explained how Check-Cap’s technology worked. Patients swallow some contrast agent and the Check-Cap 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 collected 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.

As revolutionary as this sounds, getting to it has taken longer than expected.

A press release from February 2012 announced that GE invested an undisclosed sum in Check-Cap as well as signed a broader supply collaboration agreement. Under the terms of that agreement,  “GE Healthcare–Israel will develop, design and produce miniature Cadmium Zinc Telluride (CZT) diagnostic imaging sensors inside each Check-Cap capsule to enable clinicians to obtain full 360-degree imaging as the capsule travels in the colon.”

That news release declared that Check-Cap, led by Neev, would introduce the ingestible, X-ray pill in the European Union in 2013 upon CE Mark.

Thursday’s announcement showed that the timeline has been delayed dramatically. Check-Cap is currently conducting a multicenter clinical feasibility trial and expects to submit an application for CE Mark in the first half of next year.

“When we went public (in 2015), we said that one of our objectives was to identify a partner that we could work with to increase our efficiencies from a time and cost perspective…,” Densel said in a phone interview.

But he struggled to explain the reason and the length of the delay.

“It’s a long period of time to comment on,” he said.

Still, as Densel explained how in the past 12 months the product has gotten to a place where it can now actually show that it can image polyps, it seemed to indicate that too much was promised too early.

“We did have a long history of that company and a lot of that time was spent in miniaturizing the technology,” he said. “When you think about what we are doing, we have a miniature X-ray machine in an ingestible capsule that communicates in two directions to the patch/data recorder that’s worn on the patient’s back. We’re doing single photon counting in a capsule that someone swallows. There is nothing like this in the world. Getting it to a version that was small enough to be ingestible was really where a lot of that time [was spent.]”

The idea of a prep-free, non-invasive manner to check for abnormalities in the colon has been gaining currency, especially as the first line method to screen for colorectal cancer. The hope is that non-invasive tests would boost the number of people who opt to get screened.

Exact Sciences won FDA approval for the first non-invasive DNA stool test for colorectal cancer called Cologuard in August 2014.

However, a more direct competitor to Check-Cap is Given Imaging’s PillCam, which is a similar swallowable imaging capsule that FDA approved in February 2014.

Given Imaging was bought by Covidien in 2013 and is now part of Medtronic.

Photo: Free Images.com