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New Blood Test for Colorectal Cancer Receives FDA Approval

A new blood test for colorectal cancer detection, called "Shield" and produced by Guardant Health, has received FDA approval.

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Written by: Alejandra Legarda - Journalist

A new blood test for colorectal cancer detection, called "Shield" and produced by Guardant Health, has received approval from the U.S. Food and Drug Administration (FDA). This approval will allow patients to access the test at a low cost and request reimbursement from their insurance providers. The Shield test has demonstrated the ability to detect approximately 83% of colorectal cancers, with a false positive rate of 10%, by identifying tumor DNA in the blood.

This development is particularly significant in light of a concerning increase in colorectal cancer cases among people under 50, according to data from the American Cancer Society. Colorectal cancer has become the leading cause of cancer death in men under 50 and the second leading cause in women in the same age group.

Although the Shield test is not intended for individuals at high risk of colorectal cancer, it is recommended for people aged 45 and older with average risk. Experts, such as Neil Maniar from Northeastern University, consider this test an important advancement, as it can help determine the need for a colonoscopy, which remains the gold standard in diagnosing this type of cancer.

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