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quality control and product labeling. After all, Cologuard will require patients to take a sample of their stool at home and ship it to a lab for testing.
“How clear are the directions on the labels? Are they simple enough for people to follow?” asked Jo-Ellen De Luca, a non-voting panel member representing patients. She runs Colon Cancer Solutions, a nonprofit based in Spartanburg, SC.
The Cologuard labels were originally written for a seventh grade reading level, and the instructions were revised after the clinical trial so that people with a lower reading comprehension would be able to follow the directions, said Sandra Statz, Exact’s vice president focused on clinical, quality, and regulatory issues. The company has also made minor tweaks to its collection containers to decrease leakage, she said.
Much of the discussion focused on the design of a follow-up study, which Exact has proposed would test Cologuard’s performance in 1,830 patients in at least 20 clinical sites. Exact’s proposal would have patients take an initial Cologuard test. If that came back positive, they would undergo a colonoscopy. If it came back negative, they would perform a repeat Cologuard test three years later.
But some panelists suggested the follow-up study could also involve an FIT test, and that Exact might consider running the Cologuard test on patients annually in the study, instead of only at the outset and again three years later. FIT, for example, is recommended as an annual test.
Skates admitted more frequent testing would add costs to healthcare providers and patients. But the results might definitively show whether such testing will provide meaningful—or just marginal—improvements to patient health, he said.