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Retracting Statement, ABI Will Not Seek EU, US Regulatory Approval for Avian Disease Assays

NEW YORK (GenomeWeb News) — Applied Biosystems today retracted statements made by a spokesman yesterday that the company plans to file certain pathogen-detecting assay kits with US and European regulators.
 
As GenomeWeb News reported on yesterday, ABI said it plans to develop and market pathogen-detecting assay kits through a collaboration with the UK government’s Veterinary Laboratories Agency.
 
Under the agreement, ABI will build one test kit for avian influenza and one for Newcastle disease, ABI said. Both kits, which the company said are designed to help doctors detect bird-borne diseases, will be marketed widely in Europe, Asia and Africa, but will not be available in the US.  
 
VLA will validate the assays, ABI said.
 
ABI Europe spokesman Tony Hardware yesterday said the company expects the tests to be available in the late summer.
 
However, the company this morning retracted Hardware’s statement that ABI expects to receive CE Mark certification for the kits “rather quickly,” and that the company is “involved in discussions” with US regulatory officials about seeking FDA approval to market the products in the US.
 
According to Renaldo Juanso, director of global public relations for ABI, the company “is not pursuing any regulatory clearance in any way” for the tests, which he said will be designed for research-use only.
 
Juanso described the error as a “misunderstanding.”
 
ABI said the VLA used the kits to confirm that the 2,600 turkeys that recently died in Suffolk, England, were killed by the H5N1 strain of avian flu, and were subsequently used in a follow-up survey of the region’s population of wild birds.
 
Early detection allowed for a swift containment response in this case, the company said, adding that the goal of the collaboration is to make the assays available for “the same type of early warning detection in various countries.
 
Financial terms of the agreement were not released.

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