Shares of Brea-based Beckman Coulter Inc. were down sharply Tuesday, a day after the company said issues with a profitable heart disease test could impact its 2010 results.
The Food and Drug Administration said changes to a Beckman test used to detect proteins after heart damage were made without appropriate regulatory clearances, the company reported in a Securities and Exchange Commission filing Monday.
The news sent Beckman shares down 8% in midday New York trading to a market value of $4.5 billion.
Beckman makes machines and chemicals used by hospitals and labs to run medical tests.
Its troponin tests are used to help diagnose and treat heart patients. They detect a protein that’s released into the bloodstream after the death of cardiac tissue.
Beckman said it believes it will have to limit troponin tests on its DxI machines, including switching U.S. DxI users to another form of troponin testing.
The company said the matter “may have a material adverse impact on our previously issued outlook for 2010.”
Beckman didn’t issue new sales or profit guidance.
Last month, Beckman said it expected a 2010 profit of $313.7 million to $324.4 million, in line with analysts’ expectations of $320.9 million on the higher end.
It projected sales of $ 3.8 billion to $3.9 billion, exceeding Wall Street’s projection of $3.78 billion.
Troponin tests accounted for a relatively small $60 million in U.S. revenue for Beckman in 2009, but likely make up a great share of profits.
Australia’s Macquarie Group Ltd. downgraded Beckman to “underperform” from “neutral” on the news.
