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Avian Flu-HOT ISSUE

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<p class="headline">ABI to Debut Avian Assays in Europe This Summer; Firm Chatting With FDA</p><p class="bodycopy">[March 7, 2007]</p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt 63pt; TEXT-INDENT: -18pt; mso-list: l1 level1 lfo1; tab-stops: list 45.0pt 63.0pt">&nbsp;</p><p>By <a href="http://www.genomeweb.com/cgi-bin/udt/im.author.contact.view?client_id=genomewebnews&amp;story_id=138811&amp;title=ABI%20to%20Debut%20Avian%20Assays%20in%20Europe%20This%20Summer%3B%20Firm%20Chatting%20With%20FDA&amp;author=Matt%20Jones&amp;address=http%3A//www.genomeweb.com/issues/news/138811%2D1.html&amp;summary=UPDATE">Matt Jones</a> <br /><em>a GenomeWeb News reporter</em> </p><p>&nbsp;</p><div><span class="bodycopy"><div><em>This update includes comments from an ABI spokesperson.</em></div><div>&nbsp;</div><div>NEW YORK (GenomeWeb News) &mdash; Applied Biosystems plans to make and market pathogen-detecting assay kits through a collaboration with the UK government&rsquo;s Veterinary Laboratories Agency, the company said today. </div><div>&nbsp;</div><div>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. &nbsp;</div><div>&nbsp;</div><div>VLA will validate the assays, ABI said. </div><div>&nbsp;</div><div>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&rsquo;s population of wild birds. </div><div>&nbsp;</div><div>Early detection allowed for a swift containment response in this case, the company said, adding that&nbsp;the goal of the collaboration is to make the assays available for &ldquo;the same type of early warning detection in various countries. </div><div>&nbsp;</div><div>Financial terms of the agreement were not released. </div><div>&nbsp;</div><div>ABI Europe spokesman Tony Hardware said the company expects the tests to be available in the late summer.</div><div>&nbsp;</div><div>Hardware said the company expects to receive European CE Mark certification for the kits &ldquo;rather quickly,&rdquo; and should be deploying in Europe sometime around August. The assays will be available in Africa and Asia sometime after that.</div><div>&nbsp;</div><div>ABI is &ldquo;involved in discussions&rdquo; with US officials about seeking FDA approval to market the products in the US, Hardware said, but he could not estimate a timetable for a US deployment. </div></span></div><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt 63pt; TEXT-INDENT: -18pt; mso-list: l1 level1 lfo1; tab-stops: list 45.0pt 63.0pt"><br /><br /></p>
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