In Israel, the C-Scan Capsule for Colorectal Cancer Screening Successfully Tested
The Israeli diagnostic company Check-Cap, which develops and manufactures C-Scan, the first and only "smart" capsule for the prevention of colorectal cancer through timely detection of precancerous polyps, recently reported positive results from a study evaluating the clinical effectiveness and safety of the new screening method. The capsule testing took place after its approval by European regulatory authorities and receiving CE marking.
A multicenter prospective study was designed to determine the operational characteristics of the capsule and assess its ability to detect precancerous polyps compared to the fecal immunochemical test (FIT), which is commonly used for non-invasive screening of colorectal cancer. Standard colonoscopy was chosen as the control method.
The study involved 90 patients who either already had polyps detected or had an average risk of developing colorectal cancer. Each of them swallowed the C-Scan capsule and underwent a fecal immunochemical test, after which all participants underwent comparative colonoscopy performed by independent gastroenterologists who were unaware of the previous test results.
The primary criterion for evaluating the effectiveness of the method was its sensitivity (the ability to accurately identify patients with polyps) and specificity (the ability to accurately identify patients without polyps) in detecting pathological formations larger than 10 mm, and their comparison with similar indicators of the fecal immunochemical analysis.
According to the results, the sensitivity of the C-Scan capsule was 76%, and specificity was 82%, while the FIT test showed these indicators at 29% and 96%, respectively. Furthermore, the "smart" capsule was able to detect all four patients with polyps larger than 40 mm, while the immunochemical analysis detected only one. Overall, the C-Scan method demonstrated a sensitivity of 66% compared to 23% for FIT. At the same time, researchers noted that no serious side effects were observed after using the capsule, and those that did occur were mild or moderate.
"We are pleased to share the inspiring results of our study, which once again confirmed the enormous potential of the C-Scan capsule," says Check-Cap CEO Alex Ovadia. "The completion of this experiment with a much larger sample size is an important milestone in the process of developing and launching the screening capsule in the American market and then globally, as it provides us with additional data for large-scale studies in the USA that we plan to start next year."
Professor of Internal Medicine and Gastroenterology Nadir Arber, head of the Cancer Prevention Center at the Sourasky Medical Center in Tel Aviv, adds: "The final results of the post-marketing study confirm the potential clinical value of the C-Scan technology. They also demonstrate progress in detecting large polyps that have a high potential for malignant transformation. There is a huge unmet need for a patient-friendly and non-preparatory screening method that detects polyps in the intestine before they turn into cancerous tumours."
He notes that while colorectal cancer can be prevented through timely detection of precancerous polyps, the population screening coverage remains low due to the need for bowel preparation involving laxatives, sedation, and the invasiveness of existing screening methods. "I am impressed by the potential of the C-Scan capsule to reduce the global incidence of colorectal cancer, and I can't wait for this innovative product to be available in clinics around the world," says the professor.
Check-Cap is currently conducting a trial study in America to assess the safety and convenience of the new technology. It is taking place at New York University School of Medicine and the Mayo Clinic, which is one of the largest private medical and research centers in the world.
The developers intend to continue collecting clinical data through additional studies to better prepare for large-scale trials. Given the positive results of the already conducted experiments, the company plans to start a pivotal study among people at average risk for polyps and colorectal cancer in mid-2020.
The C-Scan technology has already received CE marking, which confirms its compliance with the essential requirements and standards of the European Union, and has also been approved by the Israeli Ministry of Health for sale in the country.
About Colorectal Cancer
Colorectal cancer is one of the most common types of oncology. Approximately two million new cases are registered each year, and nearly 900,000 people die from related causes. Most malignant formations in the intestine develop from polyps – pathological growths that form on the inner surface of the colon or rectum. Their transformation into cancerous tumours usually occurs over ten years. Thus, the detection of polyps is the most effective method for preventing colorectal cancer.
About Check-Cap
Check-Cap is promoting and developing the C-Scan technology, the first and currently only swallowable scanning capsule that does not require prior preparation, designed to prevent the development of colorectal cancer by detecting precancerous polyps. Patient-friendly, it can help increase population screening coverage and reduce overall colorectal cancer incidence.
The C-Scan capsule uses ultra-low doses of X-ray radiation to scan the intestine. It has built-in systems for tracking position, controlling, and recording data, as well as original software for creating a three-dimensional map of the inner lining of the colon. The technology is non-invasive and does not require prior preparation or sedation, allowing the patient to continue with daily activities – the capsule moves through the digestive tract using natural motility, passively collecting data and transmitting it via radio communication. It then exits the body with the stool.