BioCentury
ARTICLE | Strategy

mDx blueprint

Lessons from Cologuard on overcoming molecular Dx reimbursement obstacles

May 6, 2017 3:20 AM UTC

Thanks to a well-planned robust pivotal trial and a dose of good timing, Cologuard from Exact Sciences Corp. is enjoying one of the steepest launch trajectories of any molecular diagnostic. After 10 quarters of sales, the biotech is now within striking distance of profitability.

The test’s development path, and management’s decision to focus on reimbursement from an early stage, provide lessons for other mDx players hoping to achieve rapid and broad coverage...