Small Study Supports New Stool-Based Colon Cancer Test

A new, however small, observation finds more evidence that a currently authorized, stool-based total colon cancer check can be effective for certain sufferers. Still, professionals who looked at the findings are confused that the take look, called Cologuard, has never been used for the “gold standard” colon most cancers check, colonoscopy. Cologuard is a noninvasive stool DNA check that detects crimson blood cells and positive DNA mutations associated with colon cancer. The test was accredited using U.S. Meals and Drug Management in 2014.

The new study blanketed nearly 400 people at average threat for colon cancers, meaning they had no signs and symptoms and no non-public or own family records of the disorder or precancerous polyps. The patients had also now not gone through more invasive screening strategies, which included a colonoscopy. At 12 months of complying with-up, 51 of the patients (approximately 15 percent) had a positive result at the Cologuard test and were referred for colonoscopy, said a crew led by Dr. Mark Prince of USMD medical doctor offerings, a health device based in Dallas. Of the 46 patients who acquired a complied with-up colonoscopy, 4 have been identified with colon cancer, 21 with advanced polyps (indicating a heightened risk for most cancers), and 9 with non-advanced polyps.

The findings have been offered Tuesday at the Yankee Academy’s annual assembly for most cancer studies (AACR) in New Orleans. Studies provided at meetings ought to be regarded as initial till posted in a peer-reviewed magazine. “Colon, most cancers screening, saves lives,” Prince said in an AACR news release. “Colonoscopy is the great form of colon cancer screening, however for patients who will no longer have a colonoscopy, a noninvasive screening take a look at it like Cologuard is wanted.”

But, “despite the supply of diverse colon cancer screening alternatives, greater than forty percent of American citizens are not getting screened,” he delivered. “This examination highlights the possibility to enlarge the screening populace with the aid of imparting new, affected person-friendly strategies.”

Prince is likewise a speaker for specific Sciences Corp., the Wisconsin-based maker of Cologuard. Professionals in colon cancer care agreed with Prince that colonoscopy is the attempted and genuine technique of recognizing most colon cancers. They accept as true that brand-new studies have their flaws. “The observe lacks a real assessment of the advantage of this take a look at as their affected person selection is pretty confined [46 patients],” said Dr. Jules Garbus, a colorectal surgeon at Winthrop-university sanatorium in Mineola, N.Y.

He believes that whilst the Cologuard check may be a great addition to screening, colonoscopy “stays the gold fashionable inside the prevention of colorectal cancer.” Dr. David Bernstein is chief of hepatology at Northwell Health in Manhasset, N.Y. He pointed to the consequences of a recent take look inside the New England Journal of medication that observed that the Cologuard test had the most effective 42 percent sensitivity meaning that it could most effectively correctly spot a precancerous boom less than 1/2 of the time.

“The sensitivity of the test, specifically for precancerous polyps, is unacceptably low,” Bernstein stated, and “Cologuard ought to now not be used as a substitute for colonoscopy while the better take a look at, colonoscopy, is available.” Bernstein also reiterated that the observed size of simply 46 patients is just too low to come back to company conclusions about Cologuard.

“Similarly, no longer all colon cancers have the predetermined DNA mutations measured via Cologuard,” Bernstein stated, “that means that different cancers may be missed with the aid of this check, and we do not realize the fake-bad rate of Cologuard.”