My PCP has been telling me that this is coming On Mayo's research page:
Accurate, noninvasive colon cancer test coming in 2014
May 2, 2014
If you or your patients are due for colorectal cancer screening and are seeking an alternative to colonoscopy, there will soon be a new, accurate, noninvasive option.
The test is Cologuard, which is based on an assay of DNA in stool. It reliably detects colorectal cancer at all stages as well as the most advanced precancers. “Based on extensive validation studies, Cologuard has been shown to be just as sensitive as colonoscopy for detection of colorectal cancer,” says Seth Sweetser, M.D., Gastroenterology.
Mayo Clinic will be among the first to offer this test that may substantially lessen anxiety, inconvenience and indecision associated with conventional screening.
Colorectal cancer is the second-leading cause of cancer death in the U.S. “One-third of screening-eligible patients, ages 50 to 80, have never been screened, and many others fail to adhere to repeated routine screening,” says Dr. Sweetser. He’s charged with integration of the clinical implementation of the Cologuard test across the institution. “It is our hope that we not only increase screening numbers with this new tool, but also decrease cancer incidence and mortality in doing so.”
David Ahlquist, M.D., Gastroenterology, and his research team, worked with Exact Sciences to co-develop the stool DNA test. “When we started nearly 20 years ago,” he says, “we conceived of an ideal screening test that would be highly accurate; noninvasive; free of sedation, cumbersome bowel preparations, medication restrictions and diet changes; and be able to be done from home without taking time away from work or daily activities.”
Cologuard is a match on all fronts.
At home, patients collect a stool sample that is mailed to the laboratory for evaluation. “The test is as highly sensitive at detecting advanced precancerous polyps and early-stage cancers, when treatment intervention is most effective,” says Dr. Ahlquist. Results of a multicenter study were published online on March 20 in the New England Journal of Medicine and covered in the Mayo Clinic News Center.
On March 27, the U.S. Food and Drug Administration's (FDA) Advisory Panel unanimously determined the test was safe, effective and showed a favorable risk-benefit profile. The panel chair publicly stated that he considered Cologuard to be the most important innovation in cancer prevention in two decades.
Full FDA approval is expected by the end of June. And, for the first time ever, Medicare is conducting a parallel review to set reimbursement rates.
“We are preparing to offer the test to patients before the end of the year,” says Dr. Sweetser. At Mayo Clinic, Cologuard will be offered as a choice to patients ages 50 and older who have no personal or family history of colon cancer.
“If the Cologuard test results are positive, indicating the presence of cancer or precancer, a patient will need a colonoscopy to remove polyps in the colon,” says Dr. Sweetser. When Cologuard is negative, a follow-up test is recommended every three years.
Many details on the rollout of Cologuard are yet to be determined, and it may take some time to develop and refine best practices. For example, it’s uncertain how Cologuard might be used for surveillance testing if only low-risk polyps have been removed in previous colonoscopies. Dr. Sweetser already is planning studies to look at screening rates, polyp detection and, eventually, cancer mortality rates before and after Cologuard implementation.
Once the final approval comes from the FDA and Medicare, other institutions will offer Cologuard, too. Exact Sciences in Madison, Wis., initially will serve as the national reference laboratory for Cologuard.
CP has been telling me that this is coming.
Finally a new noninvasive colon screening
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If you are having symptoms such as D or bleeding, hopefully the protocol will still be for a colonoscopy with biopsies.
That is interesting though. My husband is 8 years older than me and has yet to have a colonoscopy. I am 57 & have had 3, lol. I'm the one that has had issues and he hasn't. His mom died of colon cancer in the seventies. He should have had at least one but he is stubborn, lol.
That is interesting though. My husband is 8 years older than me and has yet to have a colonoscopy. I am 57 & have had 3, lol. I'm the one that has had issues and he hasn't. His mom died of colon cancer in the seventies. He should have had at least one but he is stubborn, lol.
Brenda