New tests may lessen need for colonoscopies
Two new DNA-based tests hold the promise of detecting early, and sharply reducing, colon cancer, a disease that afflicts 150,000 Americans a year and costs an estimated $14 billion to treat.
The new tests could help most people avoid colonoscopies, which are routinely prescribed for people older than 50.
Instead of screening the entire population, doctors could instead refer people for a colonoscopy only if they had tested positive in one of the DNA tests.
Unlike a colonoscopy, in which a seeing tube is threaded up the colon, the DNA tests are noninvasive, so more people would take them. Both tests could be brought to market within two years.
One of the tests, developed by Exact Sciences of Madison, Wis., looks in stool samples for the presence of four altered genes that are diagnostic of colon cancer. The test could catch cancerous and precancerous tumors at an early stage, when they are curable, and allow doctors to remove them promptly.
The other test looks in blood for changes in a single gene, called Septin 9, which is not in the Exact Sciences’ panel of four genes. The test has been developed by Epigenomics AG, in Germany.
Exact Sciences plans to enlist several thousand patients in a prospective trial designed to win the Food and Drug Administration’s approval. The trial will be completed in 2012 and the test, if approved, should be available shortly thereafter.
“If widely used, and regularly, this test really does have the opportunity to eliminate colon cancer,” said Dr. David A. Ahlquist of the Mayo Clinic, an adviser to Exact Sciences.
“With stool tests, you need a 90 percent specificity,” said Dr. Bert Vogelstein of Johns Hopkins University, who is also an adviser to the company. “Exact Sciences has gotten close to that. There’s a lot of hope for getting a stool-based test.”
Promising results for the blood-based tests were reported this week at a meeting in Barcelona, Spain.
Proponents of each test note possible weaknesses in the other.
Dr. Achim Plum, a vice president for Epigenomics, said 30 percent to 40 percent of people have small polyps, but that fewer than 10 percent of the polyps ever become cancerous. The stool-based test might pick up too many of these, sending far too many people in for a colonoscopy.
But the blood-based test might have a similar problem, since a positive signal could come from cancers anywhere in the body. If the patient is advised to take a whole body-imaging scan, more false positives could be generated “so you end up doing more harm than good,” Vogelstein said.
New tests may lessen need for colonoscopies
Tags: Colonoscopy, several thousand, stool samples, madison wis, dr david, mayo clinic
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