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.
Mechanism Controlling Multiple Sclerosis Risk IdentifiedNews
Researchers at Karolinska Institutet have now discovered a new mechanism of a major risk gene for multiple sclerosis (MS) that triggers disease through so-called epigenetic regulation. They also found a protective genetic variant that reduces the risk for MS through the same mechanism.
Synthetic DNA Shuffling Enzyme Outpaces Natural CounterpartNews
A new synthetic enzyme, crafted from DNA rather than protein, flips lipid molecules within the cell membrane, triggering a signal pathway that could be harnessed to induce cell death in cancer cells. Researchers say their lipid-scrambling DNA enzyme is the first in its class to outperform naturally occurring enzymes – and does so by three orders of magnitudeREAD MORE
Antarctic Worm and Machine Learning Help Identify Cerebral Palsy EarlierNews
A research team has released a study in the peer-reviewed journal BMC Bioinformatics showing that DNA methylation patterns in circulating blood cells can be used to help identify spastic cerebral palsy (CP) patients. The technique which makes use of machine learning, data science and even analysis of Antarctic worms, raises hopes for earlier targeted CP therapies.