ACR said it's only fair to approve CT colonography (also known as virtual colonoscopy) for screening as well, since it's a better test than colon cancer screening with stool DNA.
The DNA stool test (Cologuard, Exact Sciences) was approved on August 12 under a joint review process by CMS and the U.S. Food and Drug Administration (FDA). It is being marketed as a test for individuals who refuse to undergo conventional colonoscopy or sedation, and it costs about $600 per exam. Physicians submit part of a stool sample collected from the patient to test the DNA for alterations associated with colon polyps and cancer.
"CT colonography outperforms the DNA test, so why has the DNA test been approved and CT colonography has not?" ACR spokesperson Shawn Farley said to AuntMinnie.com. "What we're asking for is consistent application of the evidence-based requirements for Medicare payment approval."
Cologuard manufacturer Exact Sciences said its test can detect up to 92% of colon cancers and 67% of advanced precancerous polyps, but the company allows that false-positive results occur in about 13% of cases, and individuals testing positive will still need a colonoscopy to confirm the results.
Proponents of CTC believe that in addition to being a more accurate test, CTC could be tapped to perform follow-up exams after DNA tests to rule out false positives.
In seeking approval for its DNA test, Exact Sciences basically bypassed the U.S. Preventive Services Task Force (USPSTF) to receive approval while CTC waits, even though the DNA test doesn't perform nearly as well as CT colonography in spotting cancerous and, in particular, precancerous polyps, Farley said.
"The main thrust of our argument is, why has this test been approved and CTC is still waiting?" Farley said.
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