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Beckman Coulter Delays FDA Filings For Key Heart Test To 3Q

By Jon Kamp Of DOW JONES NEWSWIRES Beckman Coulter Inc. (BEC) has pushed back the timeline for two important U.S. regulatory filings, which the company needs to clear a test for heart problems it recalled last year, to the third quarter. The company had long maintained that it expected to file Food and Drug Administration applications for the so-called troponin test in the first half this year. But citing progress in an ongoing clinical trial, talks with the FDA plus internal compliance and quality efforts, the company disclosed a delay to that timeline in a filing with the Securities and Exchange Commission Monday. Beckman is filing two applications two cover the test's use with different systems. The Orange County, Calif., company recalled the test in question, which measures a protein that signals heart problems, due to faulty results. Beckman last year also came under fire from the FDA, which believed the company marketed that test without the needed agency clearance. Danaher Corp. (DHR), which is buying Beckman for $5.87 billion, has said that Beckman's heart-test issues were a key area of focus. Danaher Chief Executive H. Lawrence Culp Jr. said in February that the test could get back on the market by year-end, although he also said Danaher has "allowed ourselves a little bit of wiggle room." A Danaher spokesman could not be reached for immediate comment Monday. The company in late March said it was extending its tender offer to acquire all outstanding Beckman shares to April 27. Beckman shares recently traded down 18 cents to $82.97, near the planned take-over price of $83.50 per share. Danaher shares were recently down 2.6% to $51.35. -By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

Stock News for Beckman Coulter (BEC)
DateTimeHeadline
06/28/201113:48:41CORRECT:Danaher In Market With Offering To Help Fund Acquisition
06/17/201104:07:36EU Clears US Technology Firm Danaher To Buy Beckman Coulter
04/18/201111:54:16Beckman Coulter Delays FDA Filings For Key Heart Test To 3Q
02/25/201112:38:49PerkinElmer Isn't For Sale, CEO Says; Shares Slide
02/24/201111:44:18PerkinElmer, After Beckman-Bid Loss, Is Mulling Deals -Bloomberg
02/07/201116:48:21Beckman Deal Moves Danaher Deeper Into Technology Sector
02/07/201108:14:50Danaher Agrees To Acquire Beckman Coulter For $5.87 Billion
01/28/201114:25:16KKR Said To Drop Out Of Beckman Coulter Bid Group -Bloomberg
07/06/201015:19:05FDA Warns Beckman Coulter On Marketing Of "AccuTnI" Heart Test
05/14/201009:52:56Beckman Coulter Expects First Half 2011 Troponin Filing
12/17/200917:11:22Beckman Coulter Targets Mid-Teens Earnings Growth In 2010

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