Beckman Coulter (NYSE:BEC)
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5 Years : From Apr 2012 to Apr 2017
Beckman Coulter Inc. (BEC) said Friday that it expects to file an application in the first half of 2011 seeking Food and Drug Administration approval for a test used to diagnose heart problems, after running a required clinical study.
The company earlier this year recalled so-called troponin tests on its DxI automated immunoassay systems because of faulty results. The FDA, meantime, said it believed certain modifications to the troponin tests on Beckman's DxI and Access systems were made without getting proper clearance from the agency.
In a regulatory filing Friday, Beckman said the FDA recently provided guidance on the type of information the agency wants in an application. The FDA is requiring "a prospective clinical study" to achieve clearance of all troponin tests going forward, Beckmam said. The company is implementing the FDA's guidance.
The company said its "internal studies have validated that our troponin test performs in accordance with evolving clinical practice." Based on this information and talks with the FDA, the company expects to conduct a clinical study and submit a so-called 510(k) application for its troponin test on its DxI and Access instruments in the first half of next year.
The company added that it expects there will be separate submissions for DxI and Access instruments.
The maker of medical tests has noted that it had about $60 million in U.S. troponin sales in 2009, with an estimated $10 million to $15 million of that coming from tests run by customers with just DxI systems. Beckman posted total sales of $3.26 billion last year.
During the Orange County, Calif., company's earnings call in April, Chief Executive Scott Garrett said Beckman continued to work with the FDA on establishing an "unambiguous" pathway to cleared troponin status in the U.S. The company didn't estimate at that time how long a clinical trial might take, or when it might resolve these issues.
Beckman shares were inactive in premarket hours Friday. They are down about 6.7% on the year.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728; email@example.com