USMD study highlights opportunity to expand screening & detect curable-stage cancer. 

Offering Cologuard to Medicare beneficiaries who were previously noncompliant with colon cancer screening was shown to increase screening compliance rates, according to an article published this month in the World Journal of Gastroenterology. The study population comprised Medicare beneficiaries who were at average-risk for colorectal cancer, which includes people who had no symptoms and no personal or family history of colorectal cancer or polyps.

The peer-reviewed study demonstrated that when physicians at USMD, a multi-specialty health system in the Dallas area, offered patients who were not previously compliant with colorectal cancer screening (more than 10 years since last colonoscopy or more than one year since last fecal occult blood test) the opportunity to undergo screening with Cologuard, 88% completed the Cologuard test and 96% of the patients who tested positive with Cologuard completed a subsequent diagnostic colonoscopy

USMD clinicians offered Cologuard to 393 of these patients and 347 completed the test. The Cologuard result was negative in 296 patients and 51 patients tested positive.

Nearly all of the patients (49 of the 51) who received a positive Cologuard result went on to undergo a diagnostic colonoscopy. Two patients did not respond to physicians’ attempts to follow up. Among the 49 patients who had the follow-up colonoscopy, four were diagnosed with colon cancer, all early stage, and 21 with advanced adenomas, which are considered the pre-malignant polyps most at risk to develop into cancer over time. Other findings included 15 with  non-advanced adenoma and nine tested negative.

According to the article, the study results support the implementation of Cologuard in routine clinical practice, especially in patients that have been screening non-compliant. The high level of compliance with diagnostic colonoscopy in Cologuard positive patients and the high positive predictive value for advanced colorectal neoplasia (51%) validates the expenditure of colonoscopy resources in this group.

Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. Both false positives and false negatives do occur.   Any positive should be followed by a diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma.  Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established.  Cologuard results should be interpreted with caution for individuals over age 75 as the rate of false positive results increases with age.