http://blog.diagnosticsproductguide.com A comprehensive guide to cardiology products for medical professionals Wed, 29 Sep 2010 11:14:50 +0000 en hourly 1 http://wordpress.org/?v=3.1.3 http://blog.diagnosticsproductguide.com/2008/12/09/asuragen-initiates-launch-of-ce-marked-molecular-diagnostic-products/ http://blog.diagnosticsproductguide.com/2008/12/09/asuragen-initiates-launch-of-ce-marked-molecular-diagnostic-products/#comments Tue, 09 Dec 2008 06:27:14 +0000 admin http://www.diagnosticsproductguide.com/blog/2008/12/09/asuragen-initiates-launch-of-ce-marked-molecular-diagnostic-products/ Asuragen, Inc. has announced that the Signature(R) LTx v2.0 Leukemia Translocation Panel was released as a “Conformite Europeenne” or “European Conformity” CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The CE-marked Signature(R) LTx v2.0 is a qualitative in vitro diagnostic device for use in a clinical laboratory to identify specific fusion transcripts in total RNA from whole blood or bone marrow to aid in the clinical diagnosis of translocation positive leukemias. Clinical validation studies showed 100% diagnostic accuracy in comparison to standard cytogenetic methods. This represents the world’s first Luminex-based molecular oncology IVD product.

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