NEW YORK (GenomeWeb News) – Shares of Beckman Coulter fell around 7 percent in early Tuesday afternoon trade after the firm disclosed that it will likely have to impose further restrictions on the use of its troponin test kits after discussions with the US Food and Drug Administration.
In early February, Beckman Coulter had informed customers of a positive bias in results for its troponin test kits that run on the firm's UniCel DxI immunoassay system. That notice recommended that customers using the troponin test kits discontinue use if an alternative methodology was available, the firm said. It also noted that it was working with the FDA to resolve the issues.
In a filing with the US Securities and Exchange Commission published late yesterday afternoon, Beckman Coulter said that the FDA believes the firm made modifications to the troponin test kits as used on DxI systems and on its Access systems without obtaining proper product clearances from the agency. It further stated that it believes that it will be required to "impose further restrictions or conditions on the use of troponin test kits on DxI systems in the US, and those conditions will likely include transitioning US DxI customers to some other form of troponin testing until we can obtain 510(k) clearance from FDA for troponin testing on DxI."
However, Beckman Coulter also believes it is likely that the FDA will allow it to continue to provide troponin test kits with appropriate additional notices and precautions to US customers currently using the Access systems for troponin testing.
It said that it expects to seek 510(k) clearance from the FDA for the troponin test kits for use on both the DxI and Access systems.
The firm estimated that its 2009 revenues for troponin tests were around $60 million, of which 25 percent to 50 percent came from testing done on its DxI systems. Beckman Coulter said that it cannot yet quantify the impact this issue will have on its financial results, but noted that it "may have a material adverse impact on our previously issued outlook for the full year 2010."
The firm intends to update our outlook upon the release of our first quarter results in April 2010.
In early afternoon trade on the New York Stock Exchange, Beckman Coulter's shares were down 7 percent at $64.28.