Correction: DNA Stool Test-FDA story

Published on NewsOK Modified: March 25, 2014 at 2:28 pm •  Published: March 25, 2014
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WASHINGTON (AP) — 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.

In addition, the tests were less accurate in patients of certain racial and ethnic groups, including African-Americans. The FDA will ask a panel of experts whether the tests should have special warnings for those patients, among on other questions, at its meeting later this week. The agency is not required to follow such expert advice.

Colorectal cancer is the second leading cause of cancer death in the U.S., with over 50,000 deaths expected this year, according to the American Cancer Society. Deaths from the disease have been declining for more than two decades, a development attributed to increased screening in patients ages 50 to 75. Still, only about 60 percent of people in that age group have had recommended screenings.

Colonoscopy is the most accurate test but many adults are reluctant to undergo the invasive procedure, which requires several hours under sedation as doctors probe the colon with a camera-fitted catheter. Guidelines

Blood stool tests are less accurate but can be just as effective if used every year, according to a federally-appointed panel that sets testing recommendations. A positive result doesn't automatically mean a patient has cancer but is usually a red flag that leads to confirmatory testing via colonoscopy.

Approving either of the new tests could reshuffle current testing practice, a fact reflected in the FDA's review. The agency suggests both tests would require additional follow-up studies to see how accurately they perform over several years. Neither company has offered instructions for how frequently patients should be tested with the technology, which is expected to be more expensive than traditional blood tests.



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