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The Food and Drug Administration (FDA) has officially approved Guardant Health’s innovative blood test, Shield, designed to screen for colon cancer. This groundbreaking approval marks a significant advancement in the battle against the second-leading cause of cancer death in the United States.
While not intended to replace traditional colonoscopies, Shield is poised to significantly increase screening rates through its accessibility and ease of use. Priced at $895 out-of-pocket, the test is now likely to be covered by Medicare and private insurance, broadening its availability.
Dr. Arvind Dasari of the University of Texas MD Anderson Cancer Center heralded the approval as a “welcome development,” emphasizing the potential to enhance screening rates and ultimately reduce mortality from this often preventable disease.
Shield operates by detecting cancer-related DNA in the bloodstream, boasting an 83% effectiveness in identifying colorectal cancers. It is particularly adept at spotting more advanced stages of cancer, where tumors shed more DNA. Despite its high efficacy, results indicating the presence of cancer would still necessitate a confirmatory colonoscopy.
Screening Recommendations and Implications The test is recommended every three years starting at age 45, aligning with current colorectal screening guidelines. The simplicity and non-invasiveness of a blood test could address the significant screening gap; currently, fewer than 60% of eligible individuals undergo recommended screenings.
Robert Smith, Senior Vice President of Early Cancer Detection Science at the American Cancer Society, noted, “A positive Shield test requires a follow-up colonoscopy to confirm the diagnosis. It’s essential that patients understand this is a screening, not a diagnostic test.”
The introduction of Shield follows the approval of other blood-based cancer screening tests but stands out due to its higher accuracy and specificity.
Addressing the Challenge of Colorectal Cancer Colorectal cancer remains a major health challenge in the U.S., with the American Cancer Society estimating over 53,000 deaths this year alone. The disease, however, can be effectively prevented through early detection and removal of polyps during colonoscopy, making screening crucial.
Dr. William Grady of the Fred Hutchinson Cancer Center emphasized the preventive nature of colon cancer screenings, “One of my biggest joys is removing polyps that could have turned cancerous. It’s preventable, which is why increased screening is so vital.”
As the medical community continues to battle colorectal cancer, innovations like Shield represent significant strides forward in making life-saving screenings more accessible and less invasive.
