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United States A new blood test for colon cancer just got approved by the FDA
People who dread the thought of a colonoscopy now have a less invasive option to screen for colon and other rectal cancers.
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The U.S. Food and Drug Administration (FDA) approved on Monday a new blood test for colorectal cancer (CRC) screening for adults over the age of 45.
Guardant Health’s Shield test is now the first blood test approved by the FDA as a primary screening option for CRC that meets the requirements for Medicare coverage.
The test works by looking for cancer signals from DNA shed by tumors in the blood stream.
The FDA’s decision follows a recommendation for approval from an advisory committee. In May, the committee reviewed clinical trial data that showed the test had an 83% sensitivity in detecting people with colorectal cancers and 88% sensitivity in detecting stage I, II, and III colorectal cancers. Sensitivity is the test’s accuracy at identifying people with a disease.
Although the test isn’t as good as other screening options like colonoscopies and fecal sample tests at detecting precancerous growths, the committee still recommended it because it could appeal to a significant number of people who are resistant to other screening options.
CRC is the second deadliest cancer in the United States, followed by lung cancer. Despite that, one in three people in the U.S. that are eligible for screenings do not get them, according to the Colorectal Cancer Alliance.
“In addition to performance, a screening test’s value should be measured by how accessible it is, and how likely people are to use it,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance, in a press release.
The American Cancer Society projects that over 150,000 people will be diagnosed with CRC in 2024 and the disease will be responsible for more than 53,000 deaths.
The FDA first approved a similar test by Epigenomics in 2016, however, this test — now known has ColoHelth — did not meet the U.S. Centers for Medicare and Medicaid Services minimum sensitivity threshold of 74%.
