FDA Panel Recommendation For Colon Cancer Test

The Molecular and Clinical Genetics Panel of FDA's Medical Device Advisory Committee has prescribed endorsement of the Cologuard, a home-based, noninvasive screening test for colon tumor, by a unanimous vote (10-0).

Careful Sciences, a Madison, WI-based atomic diagnostics organization, directed the biggest randomized control trial in U.S. history for non-obtrusive screening around the Cologuard. The study, whose results are distributed in the New England Journal of Medicine, put the Cologuard in a head-on test against the regular fecal immunochemical test (FIT) in a gathering of individuals who were exposed to minimal danger of colorectal disease.

FIT tests catch colon tumor by searching for blood in feces tests. However, draining is not a side effect found in every patient. Cologuard, by complexity, utilizes DNA examination and searches for changed DNA in stool made by cells shed by precancerous polyps in the colon.

Cologuard distinguishes colorectal malignancy through DNA testing of stool.

The study, led at Indiana University Medical Center–regenstrief Institute in Indianapolis, assessed 9989 members and discovered the Cologuard to be more successful in identifying colorectal malignancy than the FIT – 92.3% contrasted and 73.8% with FIT.

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The authors concluded, “In asymptomatic persons at average risk for colorectal cancer, multitarget stool DNA testing detected significantly more cancers than did FIT but had more false positive results.

“The sensitivity of the DNA test for the detection of both colorectal cancer (92.3%) and advanced precancerous lesions (42.4%) exceeded that of FIT by an absolute difference of nearly 20 percentage points,” the study says. However the authors add that FIT was more specific than the DNA test. They attribute the higher number of false positives in the DNA test to a number of participants with benign tumors (which can read positive on a DNA test) and age-related variations.

The authors also noted, “Although our study provides some of the important values for modeling, it cannot determine which test or strategy is better or preferred.”

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