An updated version of Exact Sciences’ stool-based colorectal cancer screening test detected cancer accurately in a massive study, triggering fewer false alarms than its current product, the company announced Tuesday. While the biotech plans to use the data to apply for regulatory approval, cancer specialists say they’ll need to see more details before concluding the new test is a real and meaningful improvement over the current one.
The results come from a 20,000-person study of a new version of the company’s Cologuard test, which detects molecular markers of cancer in patients’ feces. Participants in the trial, dubbed Blue-C, received either the updated Cologuard test or a so-called fecal immunochemical test, or FIT, which detects blood in stool. The new Cologuard test correctly detected cancer 94% of the time, and it correctly returned a negative result 91% of the time, test characteristics known as sensitivity and specificity, respectively.
A 2013 trial of the first iteration of Cologuard, known as DeeP-C, showed the test is 92% sensitive and 87% specific. Put differently, Cologuard returned false positive results 13% of the time in the earlier study among people who don’t have cancerous cells or cells that show early signs of transforming into cancer, compared to a 9% false positive rate with this next version of the test.