Correction: DNA Stool Test-FDA Story

Posted: March 25, 2014 at 10:51 pm

In a story March 24 about colon cancer screening tests, The Associated Press reported erroneously that the Colosure test from LabCorp is approved by the Food and Drug Administration. It has not been approved by the agency. The story also incorrectly stated that another test from Epigenomics is a stool test. It is a blood test.

A corrected version of the story is below:

FDA reviews DNA-based colon cancer screening kits

FDA has questions about accuracy of 2 screening tools that use DNA to spot colon cancer

By MATTHEW PERRONE

AP Health Writer

WASHINGTON (AP) The Food and Drug Administration is weighing the benefits and risks of two experimental colon cancer screening tests which use patients' DNA to detect dangerous tumors and growths.

FDA scientists have questions about the accuracy and the potential real-world impact of the kits from Epigenomics and Exact Sciences, according to briefing documents posted online Monday. The agency released its reviews of the tests ahead of a two-day meeting that starts Wednesday. Epigenomics' Epi proColon test uses a blood sample, while Exact Sciences Cologuard uses a stool sample.

Doctors have long used stool tests to look for hidden blood that can be a warning sign of tumors and precancerous polyps. Colon cancer is usually treatable if growths are detected and removed before they multiply and spread to other parts of the body.

Both tests under review were more accurate at detecting tumors and worrisome growths than traditional blood stool tests. However, both tests also returned more false positives reporting growths when none were actually present.

Read more here:
Correction: DNA Stool Test-FDA Story

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