New noninvasive colon cancer test hits market

Source: North
A new non-invasive test that uses a stool sample to search for evidence of colon cancer might prove to be a viable alternative for those hesitant to get a colonoscopy.
The test, called Cologuard, is sold by Exact Sciences Corp. of Madison, Wis., and detects the presence of both hemoglobin from red blood cells and the altered DNA from abnormal cells that could indicate the presence of cancer or precancerous growths. Approved by the Food and Drug Administration in August, it’s meant for those over 50 years old who are at an “average risk” of colon cancer — in other words, those who don’t have a personal or family history of polyps or related cancers.

The benefits of this sort of test are obvious, especially when contrasted with the supremely invasive colonoscopy: no cameras inserted into the large intestine, and no dietary restrictions, changes in medication, or time off necessary to prepare. The test kit is shipped directly to the patient’s house.

But although a March study found it to be more effective than an older fecal test — it detected 92 percent of colorectal cancers (compared with 74 percent with the older test) and 42 percent of advanced precancerous lesions (compared with 24 percent) — not everyone is happy with that miss rate.
Dr. Mitchell K. Spinnell, attending physician and gastroenterologist at Englewood Hospital and Medical Center, said… “You don’t want to be in that 58 percent that’s a missed polyp, and you definitely don’t want to be in that 8 percent that’s a missed cancer. These indirect ways of assessing someone’s colorectal cancer risk are really second-class compared to a direct method like colonoscopy, which provides more accurate detection and the therapeutic option of removing colon polyps.”
There is also the chance of a false positive with the test; although Cologuard was correct in eliminating the possibility of colon cancer 87 percent of the time, that means that 13 percent of patients may have had unnecessary diagnostic colonoscopies (the next step after a positive stool test).
Colorectal cancer is, among cancers that affect men and women, the third most common cancer and the second leading cause of cancer-related death in the United States, according to the Centers for Disease Control and Prevention (CDC). The CDC has said that if all age 50 and over had regular screening tests, at least 60 percent of colorectal deaths could be avoided.
Cologuard, which costs $599, is available by prescription and ordered by one’s physician — it cannot be purchased over the counter. Medicare covers the costs for eligible patients, but private insurers do not yet.

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