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The Food and Drug Administration (FDA) on Monday gave green signal to Exact Sciences Corp. for a screening test of colon cancer which is first to use DNA sequence of the patients to help detect tumors and unexplained growths that may be potentially fatal.
The Cologuard test from Exact Sciences received FDA nod for spotting irregular mutations in stool samples, which can reveal early signs of colon cancer. The patients who are detected positive for this test further undergo a colonoscopy to confirm the results.
The tests of stool samples have been commonly in practice by the doctors to look for hidden blood, which can act as early warning of precancerous polyps, tumors and unexplained growth.
According to the studies, Cologuard tests were found more accurate at detecting cancerous tumors, growths and worrisome polyps in comparison to other traditional stool blood tests.
To test the efficacy of the Cologuard test, researchers carried a study involving 10,000 patients and found that the new cancer screening test showed 92 percent of colon cancers and 42 percent of advanced polyps. On the other hand, the traditional blood screening tests just spotted 74 percent of colon cancers and 24 percent of advanced polyps.
Even if its high accuracy in detecting colon cancers and advanced polyps but Cologuard was found less accurate at correctly ruling out cancer in comparison to the older blood tests. Cologuard test reported more growths when none were actually present, hence ended up being less accurate in denying possibility of cancer.
Meanwhile, top officials Exact Sciences justified the Cologuard’s high cost citing the US huge expense of more that USD 14 billion annually in colon cancer treatment.
“We think, from a cost perspective, Cologuard represents a dramatic shift toward quality at a reasonable cost. There’s really no comparison between Cologuard and the current stool blood test,” Kevin Conroy, CEO of Exact Sciences, said in an interview.
Tumor in colon is the second leading cause of cancer death in the United States. American Cancer Society estimates show over 50,000 deaths are expected this year.