BECKMAN COULTER DXI UPDATE
The firm intends to update our outlook upon the release of our first quarter results in April 2010.
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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." Beckman Coulter has launched the next analyzer in its growing family of UniCel® systems, the UniCel DxI 600 Access® Immunoassay System. 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. 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. 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. The UniCel DxI 800 enables high-volume laboratories to accelerate immunoassay time-to-results, and includes proven chemiluminescent technology and assay. 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." 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 also noted that it was working with the FDA to resolve the issues. This study evaluates its clinical performance using five assays for detecting HBV surface antigen (HBsAg), anti-HBs antibodies, and antibodies against HBV core antigen (total anti-HBc and IgM anti-HBc) and HCV (anti-HCV) in the serum. That notice recommended that customers using the troponin test kits discontinue use if an alternative methodology was available, the firm said. Beckman Coulter introduced the UniCel DxI 800 analyser in 2004. The DxI 600 uses the same reagents as other UniCel Access systems, so the laboratory can deliver consistent patient results, no matter which Beckman Coulter immunoassay system performs the test. 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. The DxI 600 allows laboratories to decrease process steps and improve turn around time - with astounding ease of use.
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. Advances in Clinical Genomics Profiling.Work cells comprise one of the fastest-growing segments of the in vitro diagnostics market,' added Creager. The DxI 600 uses the same reagents as other UniCel Access systems, so your laboratory can deliver consistent patient results, no matter which Beckman Coulter immunoassay system performs the test. 'The DxI(TM) 600 gives Beckman Coulter another immunoassay analyzer that will be combined with UniCel DxC chemistry systems, creating a broad range of work cells that will meet a variety of customer throughput requirements. The DxI 600 allows laboratories to decrease process steps and improve turn around time - with astounding ease of use. With up to 50 reagents on-board, the UniCel DxI 600 Access Immunoassay System enables you to have the flexibility to run both routine and specialized tests with amazing simplicity. Why have 50 Reagent spaces on board? To provide the flexibility you want. UniCel(R) DxI 600 Access (R) Immunoassay System