Aug. 13--One day after federal regulators approved the use of Exact Sciences' Cologuard test for cancer, shares of the Madison company's stock rose to record levels in early trading Tuesday.
The stock, traded on the Nasdaq market under the symbol EXAS, hit $19.15 a share, up 12 percent from the previous day, before closing at $17.46, up 37 cents a share, or 2.2 percent.
Volume was high, with 14.5 million shares trading hands compared to the three-month daily average volume of 1.1 million shares.
Several analysts issued upbeat research notes about the stock after the Food and Drug Administration OK'd the non-invasive, stool-based DNA test for colorectal cancer and the Centers for Medicare & Medicaid Services (CMS) indicated it will provide some reimbursement.
The announcements are "validation of the company's unique and rigorous approach," wrote William Blair & Co. analyst Brian Weinstein. He called it a "watershed moment" for Exact, praising the company for "a well-thought-out, methodical, and at times creative approach on the science and technology, execution of a very complex clinical trial, and brilliant strategic maneuvering with the FDA and CMS."
It is the first time both agencies have approved a product at the same time. Weinstein said the FDA also raised the maximum age recommended for testing to 85 from the current 75.
CMS is expected to decide in November how much of the test's $599 cost it will reimburse. Meanwhile, Exact Sciences, 441 Charmany Drive, is just starting talks with insurance companies over payment, chief executive Kevin Conroy said.
Canaccord Genuity analyst Mark Massaro said the market for colorectal cancer diagnostic testing is "a multibillion-dollar opportunity for Exact Sciences" in the U.S. alone. He said the company's new lab, off Rimrock Road, plans to have the capacity to analyze 1 million tests per year.
Massaro, who rates the stock a "buy," raised his 12-month price target to $20 from $19.
Analyst Jeffrey Elliott, of Robert W. Baird & Co., rates the stock "outperform," with a $23 price target.
The Street, though, rates the stock a "sell," citing "deteriorating net income" and "poor profit margins."
Mayo Clinic doctor David Ahlquist, co-inventor of the test, said it is designed for "high accuracy, ease of patient use, and wide accessibility. We hope that it will make a difference and save many lives."
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