Beckman Coulter Expects First Half 2011 Troponin Filing
May 14 2010 - 9:52AM
Dow Jones News
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;
jon.kamp@dowjones.com
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