WASHINGTON, D.C. — The Food and Drug Administration (FDA) has approved the Shield test, developed by Guardant Health, Inc., for colorectal cancer (CRC) screening. This test uses blood collected in the Guardant Shield Blood Collection Kit to screen individuals who are 45 years or older and at average risk for the disease.
While the Shield test is a significant step forward, it is not a substitute for diagnostic or surveillance colonoscopy in high-risk individuals. Patients with positive results from the Shield test should still undergo a colonoscopy for confirmation.
The Shield test has shown limited detection capabilities, identifying only 55%-65% of Stage I colorectal cancers and failing to detect 87% of precancerous lesions. Despite these limitations, the test provides an additional screening option for patients and aligns with the FDA’s commitment to expanding CRC screening methods.
Colorectal cancer is the second leading cause of cancer-related deaths among cancers that affect both men and women, according to the American Cancer Society. The approval of the Shield test represents a meaningful advance in efforts to detect this deadly disease early, potentially improving patient outcomes through more accessible screening options.
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