Asuragen announces data from Signature LTx v2.0 clinical study on leukemia

Asuragen, Inc. announced today that data from a study evaluating its Signature® LTx v2.0, a CE-marked IVD test, for the multiplex detection of fusion transcripts associated with ALL, AML and CML leukemia, will be presented at the upcoming Planet XMAP Europe being held September 28 - 29, 2011 in Vienna, Austria. Joanne Mason, Clinical Scientist at West Midlands Regional Genetics Laboratory, Birmingham, UK will present the results from its evaluation of Asuragen's test and comparison of its performance to standard cytogenetic methods and other molecular methods.

The modern management of leukemia patients is based on the analysis of multiple recurring chromosomal abnormalities. At the molecular level, the chromosomal breakpoints can vary over a wide region within the genes involved and it is often necessary to identify the specific fusion sub-types expressed by leukemic cells. The Signature® LTx v2.0, a CE-marked IVD Kit, (Leukemia Translocation Panel) 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. The assay is a multiplex reverse transcription PCR (RT-PCR) amplification, followed by multiplex amplicon detection on the Luminex® 100™ IS or 200™ System. "The test showed excellent diagnostic sensitivity and specificity and was compatible with representative archived RNA samples from CML, ALL and AML patients" commented Joanne Mason. "We found that the multiplex test format and rapid time to results were very compatible with our laboratory workflow and can complement standard cytogenetic methods," added Professor Mike Griffiths, Consultant Clinical Scientist and Director of the West Midlands Regional Genetics Laboratory.