On July 29, 2024, the U.S. Food and Drug Administration (FDA) approved Guardant Health's innovative blood test to control colon cancer.
The test, also known as Shield, is not intended to replace colonoscopy, but is generating excitement among doctors because it should significantly increase the number of people screened for the second-leading cause of cancer death in the United States.
Shield was previously available to doctors as a screening tool for $895. With FDA approval, Medicare and private insurance companies are much more likely to cover the cost of the blood test, making it more affordable for patients.
Dr. Arvind Dasari, associate professor of gastrointestinal and medical oncology at the University of Texas MD Anderson Cancer Center, called the approval “a long-awaited event.” However, he warned: “We'll have to wait and see what the effect will be in terms of improved control and reduced mortality.”
The American Cancer Society estimates that more than 53,000 people will die from colorectal cancer this year. A study published in March found that The test is 83% effective in detecting it.. It works by detecting DNA released by cancerous tumors into the blood. However, it is more effective at detecting cancers at later stages, when tumors release more of this DNA. The study found that Shield detected only 13% of polyps at an early stage.
The test should be performed at least once every three years, starting at age 45, the age when colon screening is recommended. A positive test does not necessarily mean a diagnosis. If the results indicate cancer, patients still need to have a colonoscopy so doctors can see where the tumors are and how far they have progressed.
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