In late July, the FDA approved Shield, the first liquid biopsy blood test for colorectal cancer (CRC) screening that meets Medicare reimbursement requirements. The article highlights five key takeaways, emphasizing that while the test might increase screening participation, it should not replace colonoscopies due to lower effectiveness and higher costs. Experts stress the need for high sensitivity and specificity in these tests to avoid false results, warning that replacing established methods with blood tests could worsen patient outcomes.
Author: Abhay Panchal
The article highlights the evolution of surgery, particularly in gastroenterology, from invasive procedures to more precise, minimally invasive techniques. It discusses how the field is embracing innovative procedures like endoscopic submucosal dissection and transoral incisionless fundoplication, which are moving into outpatient settings. The piece underscores the limitless potential of therapeutic endoscopy, driven by the creativity of practitioners, and emphasizes the shift of complex GI procedures to ambulatory surgery centers, reflecting ongoing advancements in the field.
In the past 18 months, the FDA has approved two fecal microbiota products, Rebyota and Vowst, for treating recurrent Clostridioides difficile infections. These approvals represent significant advancements in microbiome therapeutics, offering more standardized and accessible treatment options compared to traditional fecal microbiota transplants (FMT). However, challenges remain with payor coverage, patient accessibility, and the ongoing use of non–FDA-approved FMT options, which some providers continue to support due to their broader microbial composition.
The article highlights 10 gastroenterologists who have recently made headlines for various achievements, innovations, or contributions to the field.
Biotech startups are rapidly developing blood tests claiming to detect multiple cancers early, but these tests have yet to meet the rigorous criteria required for traditional cancer screening. While promising, concerns arise over the influence of commercial interests on the standards of evidence for these tests. Experts argue that these tests must demonstrate a reduction in cancer-specific mortality to be considered reliable, and upcoming trials may be crucial in determining their true effectiveness.
Exact Sciences has begun enrolling patients in its Multi-Cancer Early Detection (MCED) Falcon Registry study, aimed at evaluating the clinical performance and impact of its MCED test. The study will involve up to 25,000 patients across multiple sites, including Baylor Scott & White and Endeavor Health, to assess early cancer detection’s effectiveness and its potential to transform cancer care. The data gathered will support the test’s future development and regulatory discussions, aligning with the broader goal of reducing cancer mortality.
The American College of Gastroenterology (ACG) and the American Society for Gastrointestinal Endoscopy (ASGE) have updated their quality indicators for colonoscopy, introducing three key updates. These include new benchmarks for adenoma detection rates, the importance of patient follow-up after colonoscopy, and enhanced guidelines for the documentation of colonoscopy outcomes. These updates aim to improve the effectiveness and safety of colonoscopy procedures.
A panel of 24 international experts developed 19 consensus statements to guide clinicians in referring patients with large nonpedunculated colorectal polyps for resection. These guidelines focus on critical factors like polyp location, size, and histopathology, as well as patient demographics and previous endoscopy findings. The aim is to improve the triage and planning of endoscopic resection techniques, ultimately reducing colorectal cancer incidence and improving patient outcomes. High-quality photodocumentation was also emphasized as essential for accurate lesion assessment.
The FDA has approved Gilead Sciences’ drug Livdelzi (bulevirtide) for the treatment of primary biliary cholangitis (PBC), a chronic liver disease. Livdelzi is the first and only approved treatment specifically targeting patients with PBC who are inadequate responders to ursodeoxycholic acid (UDCA), the standard treatment. This approval provides a new option for patients with limited treatment alternatives, potentially improving outcomes for those with this challenging condition.
Johns Hopkins Kimmel Cancer Center has developed Esopredict, a PCR-based test that helps predict the progression of Barrett’s esophagus to esophageal cancer. By analyzing DNA methylation in specific genes, Esopredict identifies patients at higher risk, enabling personalized monitoring and treatment strategies. The test has shown that patients in the highest risk group are 15.2 times more likely to develop high-grade dysplasia or esophageal cancer. This tool aims to improve early detection and reduce unnecessary procedures.