NEJM publishes results from Exact's pivotal colon cancer Dx study
The trial produced some mixed data and will face scrutiny during a March 27 FDA panel meeting
March 19, 2014 | By Mark Hollmer
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.
"NEJM is a milestone that adds momentum to the test"-that's exciting-it actually helps w/the FDA!