Checkup is advancing in an experiment to test for colon cancer – Global

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Which is traded on Wall Street at a value of $ 70 million – three times its value several months ago, announces receipt of an IDE approval from the FDA for a Pivotal experiment in C-Scan. The company expects to start a Pivotal trial in the US by the end of 2021. In response the stock soars in the pre-trading phase by over 100%.

The company is in the clinical development stages of medical diagnostics developing C-Scan, a user-friendly screening test to detect colon polyps before they can become cancerous, announced today that the FDA (US Food and Drug Administration) has approved its IDE request The company. AThis alignment allows the check-cap to begin a C-Scan pivotal trial in the United States. C-Scan is intended for subjects at moderate risk for colon cancer who are not well suited for a colonoscopy, or who refuse a colonoscopy, or subjects who have not completed a colonoscopy in full. The Pivotal test will evaluate the safety and performance of C-Scan, as well as the responsiveness of C-Scan users.

Recently in an interview with BizPortal, Alex Ovadia, the company’s CEO, sounded particularly optimistic (following the jump in the stock):
Alex Ovadia, CEO of Check-Cap, said in parallel with the report: “IDE approval is a significant milestone for Check-Cap. Now that we have this approval, we intend to enter the final phase of demonstrating the clinical potential of C-Scan in the US, with the ultimate goal being a commodity in this important market. We are in advanced dialogue with a number of medical centers, preparing to launch the Pivotal trial at the end of the year. 2021. At the same time, as previously reported, we will continue to optimize C-Scan performance and user experience by collecting additional clinical data on sites in Israel, for which we are preparing to begin an experiment in Israel at more than 10 medical centers, which will recruit up to 250 subjects in Israel. Those with an average risk of colon cancer. ”

Ovadia added: “We are also pleased to announce that the FDA has approved the company’s request to grant it the status of a Breakthrough Device Designation designed to identify patients in the population at average risk for colon cancer who are at high risk for 1 cm polyps.” M or more, and have a poor fit for colonoscopy. We believe that receiving this groundbreaking status highlights the FDA’s recognition of C-Scan as an alternative screening test that meets the significant need for patient – friendly colon screening tests that are currently unanswered, particularly as it allows for the detection of colon polyps before. That they may become cancerous.

Also, current guidelines for performing colon cancer screening tests, published in March 2021 by the American Association of Gastroenterology (ACG), recommend colon pills as an alternative to performing a colon scan among subjects who are unwilling or unable to perform a colonoscopy or examination Fecal occult blood (FIT). Because performing a screening test to detect precancerous polyps provides an opportunity for early intervention and prevention of colon cancer, C-Scan may be considered an alternative for those patients, subject to its approval. ”