FDA Approves First Blood Test for Colon Cancer Screening

Colon Cancer Screening: The test could increase the number of patients who receive screening for colorectal cancer.

The Food and Drug Administration (FDA) has approved a new colorectal cancer (CRC) blood test.

Shield is a test created by Guardant Health in California. It is the first approved blood test that will serve as the primary screening option for the disease. Additionally, the company said the test meets Medicare coverage requirements.

The FDA’s approval comes after a clinical trial that included 20,000 average-risk adults. The study showed Shield had an 83% sensitivity for detecting colorectal cancer. The study results were published in The New England Journal of Medicine in March.

Robert Smith, Ph.D., senior vice president of Early Cancer Detection Science for the American Cancer Society, says that Shield is the only blood test currently available for CRC screening.

“It compares favorably with other colorectal cancer screening tests,” such as colonoscopy, CT colonography, and stool tests, Smith told Fox News Digital.

“It offers the potential to detect colorectal cancer in a person who is non-adherent with screening recommendations, asymptomatic, and willing to get this test based on preference, convenience, or both,” he added.

Smith says the major advantage of this test is that it can be done during a routine doctor’s visit; patients will not have to take time off work or be sedated for the screening.

The test does come with some disadvantages. According to Smith, the Shield test cannot detect polyps, which can serve as a precursor to CRC. If polyps are detected during a colonoscopy, they are removed and tested for signs of cancer.

According to the National Colorectal Cancer Roundtable, more than one in three adults aged 50 to 75 are not getting the recommended CRC screening.

Dr. Daniel Chung, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, believes the Shield blood test may encourage more people to get the recommended screenings.

“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” Chung said in a Guardant press release.

“The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible. With increased screening rates and early cancer detection, many more lives can be saved,“ Chung said.

For more information about the Shield Test, visit the Guardant website.