Cologuard

Question 1

What are high risk factors for CRC?

Answer 1

Family history
personal history
adenomas
IBD
hereditary CRC syndrome
cystic fibrosis
abdominal/pelvic radiation

Question 2

What are modifiable risk factors for CRC?

Answer 2

Smoking
Diabetes
Weight
Physical activity
Alcohol
Diet

Question 3

What are nonmodifiable risk factors for CRC?

Answer 3

Age
Personal history
family history
Inherited syndromes
Race

Question 4

Does a patient with a history of polyps eligible for mt-sDNA testing?

Answer 4

If benign, then possibly if they meet all other indications. Recommendations for 20+ hyperplastic polyps with certain criteria may require other management.

Question 5

Are nonadvanced adenomas a contraindication to Cologuard?

Answer 5

Yes

Question 6

Are breast cancer and prostate cancers a contraindication for Cologuard?

Answer 6

No and they are not included in CRC screening guidelines.

Question 7

What’s the maximum age for use for Cologuard

Answer 7

Based on the label, there is no maximum age. However, based on guidelines, individualized decisions can be made based on patient health, comorbidity, life expectancy, and other factors.

Question 8

*Baseline demographics for DEEP-C?

Answer 8

84.1% white
10.7% Black
2.6% Asian
9.9% Hispanic (not mutually exclusive)

Question 9

How did sensitivity in DEEP-C varies by racial demographic?

Answer 9

Lower sensitivity in Black, may have been due to lower number of CRC cases vs white

Question 10

What is racial disparity of CRC by incidence and mortality?

Answer 10

Highest incidence in American Indians/Alaskan Natives (50 and 19.0 per 100,000) followed by black (40.8 and 17.7) vs All Races (35.3 and 13.2)

Question 11

Does anticoag, antiplatelet, NSAID, or Aspiring increase rates of false positive?

Answer 11

According to Stanfield 2023, use of these meds increased total positive tests but did not impact true positive cases.
Anderson 2022 showed through regression analysis that positive mt-sDNA results were not impacted by anticoag use

Question 12

Can people with colostomy bag or partial colon resection use mt-sDNA?

Answer 12

Yes, except if the colostomies or resection were results of IBD, CRC, or cancer related conditions.

Question 13

Can Cologuard be used with history of chemo or radiation?

Answer 13

Exact recommends waiting at least 60 days to collect sample.

Question 14

Can patients with anemia use this test?

Answer 14

Patients with mild iron deficiency with identified cause are not ]\
specifically contraindicated. Has not been studied in people with anemia.

Question 15

What are “Related Cancers” based on Cologuard Clinical Brochure?

Answer 15

cancer in the respiratory or digestive tract that includes the lips, mouth, tongue, nose, pharynx (throat), vocal cords, and parts of the esophagus and windpipe, as well as the stomach, small intestine, large intestine, rectum, and anus. It also includes the salivary glands, liver, gallbladder, and pancreas.