The CE-marked Signature LTx v2.0 is a qualitative in vitro diagnostic (IVD) 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, said Asuragen. Clinical validation studies showed 100% diagnostic accuracy (95% confidence interval 93.8 to 100%) in comparison to standard cytogenetic methods, the company added.
According to the company, 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 comprehensive information on 12 different fusion transcripts associated with acute lymphoblastic leukemia, acute myeloid leukemia or chronic myeloid leukemia and an internal control in a single test.
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, said Asuragen.
Matt Winkler, chief scientific officer and CEO of Asuragen, said: This launch signifies the transformation of an established research product into a clinical assay that provides fast and accurate results needed to aid in leukemia diagnosis and subsequent therapeutic decision making.