FDA Approves New Blood Test for Colon Cancer Screening

Today, the Food and Drug Administration (FDA) granted approval for Guardant Health’s new blood test, Shield, to screen for colon cancer. This decision could significantly impact the rate of screenings for the second-highest cause of cancer deaths in the U.S. The test is designed for individuals aged 45 and older who are at “average risk” for the disease.

While Shield offers a less invasive and quicker alternative to colonoscopies, specialists emphasise that it does not replace the gold standard of colorectal cancer screening. Colonoscopies are more accurate, particularly in detecting precancerous polyps and are recommended every 10 years compared to the Shield test’s recommended interval of every three years. Robert Smith of the American Cancer Society cautioned that a positive Shield test requires confirmation through a colonoscopy: “A test like this is not complete if it’s positive and you have not had a colonoscopy.”

This new approval is expected to address low screening rates; fewer than 60% of eligible individuals currently undergo recommended screenings. “The biggest problem with colon cancer right now is that there’s a significant part of the population that’s not getting screened,” said Dr. Sapna Syngal from Dana-Farber Cancer Center. He noted that the potential for the test to increase the number of people getting screened could have a significant impact on cancer detection.