By Joe Van Den Plas, In Business
Kevin Conroy can hardly be described as a riverboat gambler, but five years ago he did roll the dice out of necessity. The decision to participate in a Food and Drug Administration and Centers for Medicare and Medicaid Services parallel review of Exact Sciences’ colorectal cancer screening technology was a risk for the once-struggling company — one that had the potential to save it years of regulatory review or bring the entire product-development effort to a grinding halt.
Without both FDA approval and Medicare coverage, “we didn’t have much of a business,” Conroy admitted. “Half of the patients who need to be screened are of Medicare age, so without simultaneously getting FDA approval and Medicare coverage, it would have been very, very difficult to finance this long-term project.”
The project took five years, but the payoff came in 2014, when the parallel review determined that Cologuard, the company’s noninvasive test, delivered the most accurate results in detecting colon cancer and precancerous polyps. In March of last year, the clinical trial results were published in the New England Journal of Medicine, and later that month, the FDA Advisory Committee unanimously voted to recommend approval of Cologuard. Read more …