U.S. health regulators have given the green light to a groundbreaking blood test for colon cancer, marking a significant advancement in the detection of this prevalent cause of cancer-related deaths. The FDA has granted approval to the Shield test developed by Guardant, making it the first of its kind for screening adults aged 45 and above with an average risk of colon cancer.
While the Shield test does not replace the necessity of colonoscopies, it offers a noninvasive alternative for screening purposes. This innovative test, which can be ordered by doctors as a laboratory test for $895, detects DNA fragments released by tumor cells and precancerous growths.
Recent studies have shown that the Shield test successfully identified 83% of cancers, although it was less effective in detecting precancerous growths compared to colonoscopies. Despite this limitation, the test's performance is comparable to stool-based screening tests.
Colonoscopies remain the gold standard for colon cancer screening as they not only detect tumors but also prevent the disease by removing precancerous polyps. However, factors such as the inconvenience of taking time off work and the preparation involved, including consuming a strong laxative, deter some individuals from undergoing this procedure.
The Shield test offers a more convenient screening option, requiring only a simple blood draw. Guardant plans to launch the product in the near future, with FDA approval expected to expand insurance coverage for the test.
In the United States, colon cancer screening is recommended for healthy adults aged 45 to 75 with an average risk of the disease. Despite this guidance, the annual screening rate in the U.S. stands at nearly 60%, falling short of the 80% target set by organizations like the American Cancer Society.
This approval marks a significant milestone in colon cancer screening, providing individuals with a new, accessible method for early detection and potentially saving lives through timely intervention.
