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Noninvasive DNA-Based Colon Cancer Screen Approved — Physician’s First Watch

Medical News |
August 13, 2014

Noninvasive DNA-Based Colon Cancer Screen Approved

By Kristin J. Kelley

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

The FDA has approved a novel colorectal cancer screening test — Cologuard — that detects DNA mutations and hemoglobin in stool samples. Patients testing positive should follow-up with colonoscopy.

In a clinical trial of some 10,000 patients, Cologuard accurately detected more advanced adenomas and colorectal cancers than fecal immunochemical testing. The new test, however, did not correctly rule out cancer as accurately as the older test.

The FDA notes that this approval does not change the U.S. Preventive Services Task Force's guidelines, which recommend screening using colonoscopy, sigmoidoscopy, or fecal occult blood testing.

Reader Comments (2)

Israel Bendit MD Physician, Hematology, University

One more test that really do not help in anything, in other words, if not rule out cancer as older test so why we need such a test. Only to spent more money.

Marshall Fields Physician, Family Medicine/General Practice, Dean Clinic

" The new test, however, did not correctly rule out cancer as accurately as the older test." This comment could use much a more complete explanation ! I presume it means that Cologard is not as accurate as FOBT in identifying patients with adenomas or colorectal cancers.

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