Nearly a decade after the original Cologuard test received premarket approval from the FDA and became a blockbuster hit as a screening tool for colorectal cancer, its maker Exact Sciences is planning to release a sequel.
The next-generation Cologuard test may provide even more accurate results than its predecessor, according to study data Exact unveiled this week, and could therefore “set a new performance standard,” CEO Kevin Conroy said in the company’s announcement.
The new study results will anchor Exact’s application for FDA clearance of the next-gen test, which the company plans to submit before the end of this year.
“We are harnessing deep scientific insights, advanced technology and over a decade of research and development to detect colorectal cancer with greater sensitivity and significantly improve the false positive rate,” Conroy said. “Once approved, next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time—when there are 60 million Americans not up to date with screening.”
The BLUE-C study spanned more than 20,000 people aged 40 and older. Its participants were recruited from across the U.S. and were also reflective of the racial and ethnic diversity of the U.S., according to Exact Sciences.
When put to the test, the new Cologuard was able to detect signs of colorectal cancer with 94% sensitivity, compared to 92% for the first-generation test. It identified negative cases, meanwhile, with 91% specificity, up from 87% in the original Cologuard. The new test also produced 30% fewer false-positive results than the original.
Like its predecessor, the new iteration of the test was somewhat less successful in spotting the earliest signs of cancer, though it still edged out the former. The next-gen and original tests detected high-grade dysplasia—describing an abnormal clump of cells that may become cancerous but haven’t yet—with 75% and 69% sensitivity, respectively, and spotted advanced precancer cases with 43% and 42% sensitivity, respectively.
Altogether, per Exact, the updated test successfully met all of the study’s endpoints and also outperformed its predecessor across every metric. The company is planning on releasing more data from the study later this year.
Exact developed the new and improved Cologuard in partnership with the Mayo Clinic. The front end is much the same as the first iteration of the test, with users collecting a stool sample at home and sending it off to a lab for analysis, but that analysis is where the tests differ: The new version looks for additional DNA biomarkers in the sample, and the company said it has also improved its lab processes and enhanced the “sample stability components,” expanding the length of time that a sample can stay valid to account for shipping time and other delays.
While preparing to submit the next-gen Cologuard test for FDA clearance, Exact is already exploring the next potential addition to its colon cancer screening menu. The company noted in Tuesday’s announcement that while conducting the BLUE-C study, researchers retained blood samples from the participants for a future study of a blood-based screening test that’s currently under development.