Almac Will File Colorectal Recurrence Dx for FDA OK; Hopes to Sell IVD in '08 | GenomeWeb
NEW YORK (GenomeWeb News) — Almac Diagnostics this week said it plans to meet with the US Food and Drug Administration about starting clinical trials of an array-based colorectal recurrence test it hopes to launch next year.
 
The Craigavon, UK-based company, which has to date offered arrays for research purposes, intends to launch the assays as an in vitro diagnostic if the FDA clears its 510(k) application.
 

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