|2014 Change: 133%|
|Market cap: $2.4 billion|
Major holders at Sept. 30: The Vanguard Group (5.69%), Capital Research Global Investors (5.45%), BlackRock Institutional Trust (4.53%), Gilder Gagnon Howe (4.05%), Invesco Advisers (3.86%), William Blair (3.52%), Wasatch Advisors (3.16%) and Fidelity Management & Research (2.96%)
Why is it up? Exact Sciences ($EXAS) long pushed for expanded approval of its noninvasive colorectal cancer DNA screening test, and investors celebrated in August 2014 when the company won an FDA OK for its diagnostic tool. Madison, WI-based Exact scored the regulatory nod through a joint pilot program from the FDA and Centers for Medicare and Medicaid Services (CMS) which allows the agencies to simultaneously review medical devices to reduce time between approval and Medicare coverage. The regulatory blessing paved the way for full Medicare coverage of Exact's Cologuard test in October, setting the stage for future growth. "The past three months have been among the most significant in the company's history," CEO Kevin Conroy said during the company's third-quarter earnings call. "We are focused on educating physicians and ensuring that patients across the country know that Cologuard is a new highly sensitive, noninvasive screening option."
What comes next? With FDA approval and Medicare reimbursement in the bag, Exact Sciences is working on securing private insurance reimbursement for its Cologuard test. And investors are optimistic that the company will continue to chart growth in the coming year. In December, Exact announced a deal for 4 million shares of common stock at a price of $25.75 per share, an "offensive raise" for the company as it continues to expand commercialization for its colorectal cancer diagnostic, William Blair analyst Brian Weinstein said. "We remain strong supporters of this company and this stock and believe that the long-term opportunity for investors is unmatched by any name on our list," Weinstein said.
Exact Sciences nails coveted Medicare coverage for colon cancer DNA test
Exact Sciences bags FDA approval and proposed CMS coverage for colorectal cancer screening test
Exact Sciences raises nearly $120M, focused on a hoped-for 2014 launch of its colon cancer Dx
Exact Sciences wins unanimous FDA panel approval for its colon cancer Dx
NEJM publishes results from Exact's pivotal colon cancer Dx study
Exact will make its case on March 27 for FDA approval of a colon cancer Dx
-- Emily Wasserman (email | Twitter)