Check-Cap Ltd. (NASDAQ: CHEK) stock is skyrocketing in the early trades this morning. The shares price of CHEK stock was buoying at $3.50 rising +129% as of the writing following this morning news of a go ahead by FDA to applications of CHEK for cancer screening technology.
What actually is the news?
Check-Cap is a clinical-stage medical diagnostic company introducing the C-Scan for colorectal cancer screening. Unlike other screening tests, C-Scan requires no preparation, making it the only screening test capable of detecting polyps before they turn into colorectal cancer, enabling early detection and cancer prevention. Through the Check-Cap (CHEK)’s capsule-based screening technologies, millions of people can benefit from a preventive CRC screening and significantly increase screening adherence worldwide.
Check-Cap today announced that the U.S. Food and Drug Administration (FDA) have approved the CHEK’s Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a pivotal study of C-Scan in the U.S.
C-Scan is intended for candidates who are at average-risk for CRC and are poor candidates for colonoscopy or decline colonoscopy is, or who had an incomplete optical colonoscopy. The pivotal study will evaluate the safety and performance of C-Scan as well as subject compliance with C-Scan.
What is CRC?
Colon and rectal cancers usually start as pre-cancerous polyps or abnormal cell growths for up to a decade before developing into invasive cancer. The evidence indicates that colonoscopy can prevent CRC, yet adherence remains low due to the invasiveness of the procedure, the need for bowel preparation, and the limited access available in some communities.
Current CRC screening tests are generally too insensitive to detect precancerous polyps and are mainly used to detect cancer. Patients do not necessarily get the time to preempt the disease because they do not receive early warnings.
The need for non-invasive screening techniques to detect pre-cancerous polyps is thus unmet in medical technology. Consequently, screening for polyps is the most effective way to prevent CRC and this highlights the larger potential for Check-Cap (CHEK) to further strengthen itself in the C-Scan development.