The approval of a new blood test by the Food and Drug Administration (FDA) may transform the landscape of colorectal cancer screening. On Monday, the FDA greenlit Guardant Health's blood test, named Shield, which is poised to improve access to screening for a disease that claims more than 53,000 lives annually in the United States. The test aims to address a troubling rise in colon cancer diagnoses among younger individuals and to encourage those eligible for screening to take action.
Colorectal cancer has been on the rise since the mid-1990s, particularly among those under 55, with rates increasing by 1% to 2% each year. Despite the growing urgency, fewer than 60% of eligible individuals have undergone recommended screenings. Traditional colonoscopies, while effective, have deterred many due to their time-consuming nature and the need for patients to take at least one day off work.
Shield has been available to doctors as a screening tool at an out-of-pocket cost of $895. However, with FDA approval, it is anticipated that Medicare and private insurance companies will begin covering the test, significantly enhancing accessibility for patients. Though Shield is not intended to replace colonoscopies, it is generating optimism among healthcare providers who believe it could help boost screening rates for this second-leading cause of cancer death in the country.
Research published earlier this year indicated that Shield demonstrated an 83% effectiveness rate in detecting colorectal cancers. This promising statistic has led organizations like the American Cancer Society to recommend that screening begin at age 45 and occur at least every three years. Dr. William Grady, a gastroenterologist at Fred Hutchinson Cancer Center in Seattle, emphasized the importance of prevention, stating, “What breaks my heart is that it’s preventable.”
John Gormly, a 77-year-old resident of Newport Beach, California, provides a compelling case for the potential impact of Shield. After years of avoiding colonoscopy screening, Gormly opted for the Shield blood test, which ultimately led to a diagnosis of stage 2 colon cancer. Reflecting on his experience, he remarked, “Thank God I had taken that blood test.” He expressed concern about what might have happened without it: “Short of that blood test, I don’t know how it would have turned out.”
However, experts caution that while Shield offers a promising alternative, it has limitations. In a recent study, the test only detected 13% of earlier-stage polyps. Dr. Sapna Syngal noted, “The biggest problem with colon cancer right now is that there’s a significant part of the population that’s not getting screened.”
Colonoscopy remains an essential tool in colorectal cancer prevention and treatment. The procedure requires significant preparation, including taking a strong dose of laxatives the day before to clear the bowel. Dr. Grady shared his satisfaction with performing colonoscopies: “One of my biggest joys is when I’m doing colonoscopy and I can take out polyps.”
Despite its limitations, Shield represents a significant advancement in cancer screening technology. Dr. Arvind Dasari, an associate professor in the department of gastrointestinal and medical oncology at the University of Texas MD Anderson Cancer Center, called its approval a “welcome development.”
Nevertheless, healthcare professionals emphasize the importance of follow-up procedures. Robert Smith cautioned that a positive result from the Shield test necessitates further confirmation through colonoscopy: “People have to understand that a positive Shield test requires a colonoscopy to confirm that you have an advanced lesion or colorectal cancer, or that the results were false.”
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