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FDA advisory committee unanimously recommends DNA stool test for colon cancer
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An FDA panel unanimously voted to endorse an experimental stool test that uses DNA to detect colon cancer and precancerous growths.
The FDA’s committee of genetic experts voted 10-0 that the benefits of the Cologuard test from Exact Sciences outweigh its risks.
“We are pleased the committee strongly supported Cologuard’s approval,” Kevin T. Conroy, chairman and chief executive of Exact Sciences, said in a press release. “We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening.”
Earlier this week, the same FDA panel voted 5-4 with one abstention that the benefits of the Epi proColon kit from Epigenomics outweigh the risks.
The FDA staff’s review of Cologuard suggests Cologuard would require additional follow-up studies to see how accurately it performs over several years.
Although current federal guidelines recommend traditional blood stool samples every year for individuals aged 50 to 75 years, only about 60% of adults adhere to the recommendation.
According to company studies reviewed by the FDA, Cologuard accurately detected colorectal cancer 92% of the time in patients who had cancerous tumors, better than the 74% accuracy of traditional blood stool test. However, Cologuard also returned more false-positive results.