FDA Approves the First Device Using Artificial Intelligence for Early Detection of Colon Cancer

This new medical device helps doctors detect potential abnormalities during colon cancer screening and surveillance.

On 9 April 2021, the FDA (US Food and Drug Administration) authorized marketing of GI Genius, the first device using artificial intelligence to help doctors detect lesions in the colon (large intestine), such as polyps or suspected tumors, in real time during colonoscopy.

Artificial intelligence has the potential to transform healthcare to better assist healthcare providers and improve patient care. Combined with conventional screening or surveillance methods, AI may help find problems early, when they can be treated more easily. Research shows that lesions missed during colorectal cancer screening can be a problem even for well-trained physicians / gastroenterologists. With the FDA's approval of this device today, doctors now have a tool that may help improve their ability to detect gastrointestinal lesions they might otherwise miss.

Colorectal cancer is the third leading cause of cancer deaths worldwide and in Turkey. It generally starts as polyps or other precancerous growths in the rectum or colon (large intestine). As part of a colorectal cancer screening and surveillance plan, doctors perform colonoscopy to detect changes or abnormalities in the lining of the colon and rectum. Colonoscopy involves passing an endoscope (a thin, flexible tube with a camera at its tip) through the rectum and along the entire colon, allowing a clinician to see signs of cancer or precancerous lesions.

How Does Artificial Intelligence Help during Colonoscopy?

GI Genius consists of hardware and software designed to highlight parts of the colon where the device detects a potential lesion. The software uses artificial intelligence algorithm techniques to identify areas of interest. During colonoscopy, the GI Genius system generates markers resembling green squares, accompanied by a short, low-volume sound, and overlays them on the video from the endoscope camera when it identifies a potential lesion. These markers alert the doctor that further assessment may be needed, such as closer visual inspection, tissue sampling, testing, removal, or ablation (burning) of the lesion. GI Genius is designed to be compatible with many FDA-approved standard video endoscopy systems.

The FDA evaluated the safety and effectiveness of GI Genius in a multicenter, prospective, randomized, controlled study in Italy involving 700 subjects aged 40-80 undergoing colonoscopy for colorectal cancer screening, surveillance, previously detected fecal occult blood, or gastrointestinal symptoms of possible colorectal cancer.

The study's primary analyses were based on a subgroup of 263 patients screened or monitored every 3 years or more. Subjects underwent standard white-light colonoscopy with GI Genius (136 patients) or standard white-light colonoscopy alone (127 patients).

The study's primary endpoint compared how often colonoscopy plus GI Genius identified a patient with at least one laboratory-confirmed adenoma (precancerous tumor) or carcinoma (cancerous tumor) with how often standard colonoscopy made the same identifications.

In the study, colonoscopy plus GI Genius detected laboratory-confirmed adenomas or carcinomas in 55.1% of patients, while standard colonoscopy detected them in 42% of patients, observing a difference of 13%.

Although use of the device led to more biopsies, no adverse events / side effects such as perforation (a hole in the bowel), infection, or bleeding were reported with the additional biopsies. However, there was a slight increase in the number of biopsied lesions that were not adenomas.

GI Genius is not intended to characterize or classify a lesion (growth), or to replace laboratory sampling as a diagnostic tool. The device does not provide any diagnostic assessment of colorectal polyp pathology or suggest to the doctor how suspicious polyps should be managed. GI Genius only identifies regions within the endoscope's field of view where a colorectal polyp may be located, enabling more extensive examination in real time during colonoscopy. It is up to the doctor to decide whether the identified region actually contains a suspicious lesion and how the lesion should be managed and handled according to standard clinical practice and guidelines.

The FDA granted marketing authorization for GI Genius to Cosmo Artificial Intelligence, Ltd.