Cologuard has demonstrated improved screening rates among previously noncompliant patients

In a retrospective EHR-based medical record review from October 2014 to September 2015, 77 primary care physicians offered Cologuard to 393 patients on Medicare who were noncompliant with colorectal cancer (CRC) screening recommendations¹

0 Compliance

0 of 393 patients were compliant with recommended CRC screening.¹

88.3^% Cologuard compliance

88.3% of patients were compliant with Cologuard over 12 months.¹

96.1^% Follow-up colonoscopy

96.1% of patients who had a positive Cologuard test underwent a follow-up diagnostic colonoscopy.^1*

Study limitations: A relatively smaII study size from a single health center; findings may not be generalizable to patients not on Medicare or to patients outside this particular geographic area (Dallas, TX).¹

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^*Multitarget stool DNA test was positive in 51 patients. Diagnostic colonoscopy was carried out in 49 positive patients, with 2 patients lost to follow-up.¹

Indication and Important Risk Information 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, 45 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.

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

Positive Cologuard results should be referred to 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.

False positives and false negatives do occur. In a clinical study, 13% of patients without colorectal cancer or advanced adenomas received a positive result (false positive) and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.

Reference: 1. Prince M, Lester L, Chiniwala R, Berger B. Multitarget stool DNA tests increases colorectal cancer screening among previously noncompliant Medicare patients. World J Gastroenterol. 2017;23(3):464-471.

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