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US regulators approve blood test for screening for colon cancer

August 3, 2024No Comments3 Mins Read
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U.S. health regulators have approved a new blood test for colon cancer, offering a noninvasive way to screen for this leading cause of cancer deaths. The Shield test, developed by Guardant, is approved for adults 45 and older with an average risk of colon cancer. While the test is not meant to replace colonoscopies, it provides an alternative screening method. The test looks for DNA fragments shed by tumor cells and precancerous growths, with a study showing it caught 83% of cancers but missed some precancerous growths detected by colonoscopy. The out-of-pocket cost for the test is $895, but with FDA approval, coverage by private and government insurance is expected to increase.

Colonoscopies remain the gold standard for colon cancer screening as they can not only detect tumors but also prevent the disease by removing precancerous growths called polyps. However, some people avoid colonoscopies due to the inconvenience of taking time off work and the preparation process involving the consumption of a strong laxative to empty the bowels. In the U.S., screening is recommended for healthy adults ages 45 to 75 at average risk for colon cancer. The Shield test, which only requires a simple blood draw, aims to provide a more convenient screening option for those who may be hesitant to undergo a colonoscopy.

Guardant plans to launch its Shield test in the near future, offering physicians a new tool to screen for colon cancer. The annual rate of colon cancer screening in the U.S. is currently below the 80% goal set by organizations like the American Cancer Society. With the approval of this new blood test, it is hoped that more individuals will be screened for colon cancer, leading to earlier detection and improved outcomes. The test’s approval by the FDA is expected to increase access to the test through insurance coverage, making it more widely available to those at risk.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content. Throughout the United States, health regulators have approved Guardant’s Shield test for colon cancer screening in adults 45 and older at average risk. The test, which detects DNA fragments shed by tumor cells and precancerous growths, provides a noninvasive alternative to colonoscopies. Despite its high success rate in catching cancers, the test missed some precancerous growths found by colonoscopy. By offering a simpler screening method, the Shield test aims to increase the rate of colon cancer screening among age-eligible adults.

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