Asuragen Initiates Launch of CE-Marked Molecular Diagnostic Products
News Dec 08, 2008
Asuragen, Inc. has announced that the Signature® 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® 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, the company claims.
The assay is a multiplex reverse transcription PCR amplification, followed by multiplex amplicon detection on the Luminex® 100™ IS or 200™ system. The liquid bead array assay format provides information on 12 different fusion transcripts associated with ALL, AML, APL or CML and an internal control in a single test.
“Standard cytogenetic analysis by karyotyping or fluorescence in situ hybridization can be laborious or require multiple successive hybridizations to detect a given chromosomal translocation. Asuragen’s expertise in multiplex RNA-based assays enables the rapid molecular diagnosis of leukemia fusion transcripts and therefore improves workflow and efficiency in the clinical laboratory while nicely complementing standard diagnostic hematopathology testing,” according to Rollie Carlson, Ph.D., President, Asuragen Inc.
The Signature® LTx platform was initially launched in early 2005 as a research use only product in order to assess its potential utility in the clinical diagnostic environment. After extensive clinical evaluation at major academic medical institutions, Signature® LTx v2.0 CE IVD is now available immediately to clinical laboratories throughout the European Union.
The Signature® LTx v2.0 CE IVD assay follows the European launch of RNARetain™, Asuragen’s clinically validated and cGMP manufactured sample collection and RNA stabilization in vitro diagnostic device.