Following the recent FDA approval of Exact Sciences’ Cologuard® product, the first non-invasive, DNA screening test for colorectal cancer, the company must convince healthcare providers and consumers of the effectiveness of the product.
For Exact Sciences, it’s put up or shut up time for colon cancer test
By Jeff Engel, Xconomy
Exact Sciences CEO Kevin Conroy typically chooses his words carefully in interviews and public statements to investors, but he isn’t shy about making bold statements when it comes to the potential impact of his company’s newly-approved diagnostic test for colon cancer.
“Cologuard may represent one of the most significant advancements in cancer screening in the last couple of decades,” Conroy tells Xconomy.
That remains to be seen, but the Food & Drug Administration saw enough promise to approve Cologuard earlier this week, making it the first non-invasive, stool-based DNA screening test approved for colorectal cancer. Also this week, the Centers for Medicare & Medicaid Services (CMS) issued its proposal to cover the Cologuard test—which the company priced at $599 per patient—once every three years for Medicare patients who meet certain criteria. A final coverage decision is expected in October or November, after a public comment period, Exact says. Read more …