Exact Sciences ($EXAS) is celebrating positive results from a massive pivotal trial of its colorectal cancer diagnostic now published in The New England Journal of Medicine, an important achievement on the long regulatory road to approval.
The NEJM milestone adds some momentum to the test, which is more sensitive overall than the current standard of care. But the overall results are somewhat mixed. Expect heavy scrutiny in this regard when the Wisconsin company makes the case for premarketing approval for its Cologuard colorectal cancer DNA screening test before the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. The daylong meeting is scheduled for March 27, and the panel's nonbinding recommendations will likely influence the FDA's final decision.
Exact didn't mess around with this trial. The company's DeeP-C pivotal study looked at 10,000 patients at 90 centers in the U.S. and Canada and compared the performance of Cologuard to the standard fecal immunochemical test (FIT), a noninvasive colorectal cancer screening diagnostic. Cologuard displayed a 92% sensitivity in detecting patients with colorectal cancer, versus 74% for FIT. For patients with Stages I-III colorectal cancer, Cologuard displayed a 93% sensitivity. The FIT option achieved a 73% sensitivity by contrast.
But Cologuard's specificity reached 87%. FIT scored much higher in this regard, hitting a 95% specificity. Also worth noting, Cologuard's sensitivity in patients with advanced precancerous lesions only hit the 42% mark. Still, that's higher than FIT, which scored 24%.
Clearly, in some ways, Cologuard represents a major improvement over the status quo. Considering colorectal cancer is preventable but rarely detected until its advanced stages, a test with higher sensitivity is a major step up toward catching it sooner. Spotting precancerous lesions is an important part of early cancer detection, however. Cologuard's relatively low sensitivity in this regard, while better than FIT, will draw serious scrutiny during the company's panel meeting. The test clearly shows improvement in detecting early stages of colon cancer, but its record in identifying precancerous lesions is a weakness.
That's not an isolated sentiment. When the data first came out last April, the market punished Exact for the mixed results. The NEJM milestone seems better received. Exact traded at $15.21 early on March 19, up more than 5.7%.
Exact Sciences President and CEO Kevin Conroy said in a statement that the company is pleased with the data published in the NEJM. And he reiterated the company's stated belief that "Cologuard could be an important tool in the early detection of colorectal cancer."
Regardless, Exact's March 27 panel meeting will be closely watched. The NEJM published the study online and will include it in its April 3, 2014, print issue, according to the announcement.
- read the release
- get the NEJM article