A new colon cancer test is approved by the FDA.
A Food and Drug Administration advisory panel has unanimously voted to endorse its non-invasive experimental stool test, which relies on DNA to find colon cancer and precancerous growths.
The FDA’s committee, comprised of genetic experts, voted 10-0 that the Cologuard test’s benefits outweigh its potential risks. The FDA is not required to follow the panel’s suggestion, but often heeds its advice. This move to approve the test, from Exact Sciences of Madison, Wisc., has paved the way for a potential market approval.
“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,” said Kevin Conroy, Exact Science’s chairman and CEO.
Research has proven that colon cancer can be very dangerous, especially if it is not treated at an early stage. In some cases the disease is fatal. The test will help to detect colon cancer and precancerous growths early on. The FDA will review the test and will encourage colorectal cancer screening so that patients can avoid a last-minute rush. The tests help to prepare patients ahead of time and can save them from serious problems later on.
Doctors have used stool tests to search for hidden blood, a potential indicator of tumors and precancerous polyps, for a long time. Cologuard and similar DNA tests that are currently being developed detect small genetic changes that are linked to cancer cells in the colon.
On Wednesday, March 27, the same panel of experts voted 5-4 that the benefits from Epi proColon kit from Epigenomics is more beneficial than risky. The test collects samples of blood rather than stool.
It is anticipated that Cologuard would require follow-up studies to determine how well it performs over the span of several years. Company studies, reviewed by the FDA, showed that Cologuard correctly detected colorectal cancer 92 percent of the time for patients with cancerous tumors, a large increase from the 74 percent detection rate in traditional blood tests.