Journalists: For links to video and audio files, see the bottom of this post.
More accurate and more sensitive. When it comes to cancer screenings, those are two attributes you really want. Well, results of two studies suggest that a new, investigational colorectal cancer (CRC) screening test developed in collaboration between Mayo Clinic and Exact Sciences Inc. of Madison, Wis., is highly accurate and significantly more sensitive than other noninvasive tests at detecting precancerous tumors (adenomas) and early-stage cancer.
The screening test, called stool DNA testing, works by finding signature genetic markers in stool samples mailed in by patients. The testing can be done from home, and should be accessible wherever the mail goes.
“Colorectal cancer continues to be an enormously huge problem. It is the number two cancer killer in North America, and only about half of all adults that should be screened for colon cancer are screened for colon cancer,” says lead study author David A. Ahlquist, M.D., a Mayo Clinic gastroenterologist. A simple, accurate test will help to bring screening to more patients.
“The nice thing about the colon is that it is very accessible. A positive test would be followed by a colonoscopy to remove the polyps. And removing the polyps then, will prevent a subsequent cancer from forming,” say Dr. Ahlquist.
Journalists: The following video and audio clips are available for download and use in your stories.
Dr. Ahlquist:
Dr. Thibodeau
Broll
Lab work: MOV
Below is a link to an edited youtube video with Dr. Ahlquist and Dr. Thibodeau that you can embed with your stories.
What is the estimated time table for FDA approval for the test and how rapidly will it be made available to labs?
Multicenter validation study for FDA approval is underway and should be completed by end of this year. If approved, test should become available in 2013. From Dr. Ahlquist
The multicenter validation study for FDA approval should be completed by the end of this year, and test (if approved) will become available in 2013.
I wonder if Canadians might sign on with the Mayo Clinic, so long as the postal services or the Feds object to importing poop…
**don’t object
What are the implications of this test for virtual colonography? Could it be replacement or additive?
Thank you for your question. We are checking on an answer.
Both tests show high accuracy, but CT colonography is much more expensive, involves a bowel preparation and time away from daily activities, and is associated with a radiation exposure risk. As such, the role for CT colonography for colorectal cancer screening at the population level has not yet been endorsed by professional societies (like American Cancer Society) and is not approved by Medicare or FDA for this application.
On the other hand, stool DNA testing has already been endorsed by many professional societies, including the ACS, and approvals by both FDA and CMS (Medicare) are in process. The test is much less costly, involves no prep or diet/med restrictions, and can conveniently be done via mail.
It will be patient choice, market forces, and regulatory approvals that will determine which test is most widely used for population screening.