FDA Approves Guardant Health's Shield Blood Test for Colon Cancer Screening
The Food and Drug Administration (FDA) has granted approval to Guardant Health's blood test, Shield, for colon cancer screening. While not intended to replace traditional colonoscopies, the test is generating excitement among medical professionals who believe it could significantly improve the currently low rates of colon cancer screenings in the U.S., the second-leading cause of cancer deaths.
Previously available to doctors at an out-of-pocket cost of $895, Shield is now expected to be covered by Medicare and private insurance, making it more accessible to patients. Dr. Arvind Dasari from the University of Texas MD Anderson Cancer Center welcomed the approval but noted that its impact on screening rates and mortality will need to be evaluated.
The American Cancer Society estimates over 53,000 deaths from colorectal cancer this year. Research shows Shield to be 83% effective in detecting colorectal cancers, primarily identifying later-stage tumors. However, it detected only 13% of earlier-stage polyps. The test, recommended every three years starting at age 45, does not replace the need for a colonoscopy if the results are positive.
Robert Smith from the American Cancer Society emphasized the importance of follow-up colonoscopies to confirm results. This approval marks Shield as the second blood test for colon cancer screening, following the 2016 approval of Epigenomics’ Epi proColon, which has seen limited use due to accuracy concerns and lack of coverage.
Colon cancer rates have been rising among individuals under 55, despite declines among those older than 60. Dr. William Grady from Fred Hutchinson Cancer Center noted that early detection through screening can prevent cancer, but low screening rates persist.
Dr. Sapna Syngal from Dana-Farber Cancer Center highlighted that increasing screening rates is crucial. Shield’s approval might help address barriers to screening, such as the inconvenience and discomfort of colonoscopies.
Alternative methods like fecal occult blood tests and FIT-DNA tests are available, but the Shield test offers a less invasive option. John Gormly, who used Shield after avoiding colonoscopy, credited the test with detecting his stage 2 colon cancer, which was successfully treated following the test results.
