FDA approves first DNA-based test for colon cancer
WASHINGTON - The Food and Drug Administration has approved the first screening test for colon cancer that uses patient DNA to help spot potentially deadly tumors and growths.
The Cologuard test from Exact Sciences detects irregular mutations in a patient's stool sample that can be an early warning sign of cancer. Patients who test positive for the mutations should undergo a colonoscopy to confirm the results.
Doctors have long used stool tests to look for hidden blood that can be a warning sign of tumors and precancerous polyps.
But company studies of Cologuard showed that it was more accurate at detecting cancerous tumors and worrisome polyps than traditional stool blood tests. The new test was less accurate at correctly ruling out cancer, as it reported more growths when none were actually present.