Asuragen and Life Technologies agreed to work together on the development and distribution of an in vitro diagnostic test for monitoring chronic myeloid leukemia (CML). The test will run exclusively on the 510k-cleared Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument; Applied Biosystems is part of Life Technologies.
Asuragen will be responsible for regulatory activities in Europe and the U.S. The diagnostic will then be distributed by Life Technologies globally.
Asuragen’s in vitro test, a BCR/ABL1 assay, will be designed to simultaneously detect and quantify BCR/ABL1 fusion transcripts (b2a2, b3a2, and e1a2) in a single reaction. The BCR/ABL1 fusion gene arises from a specific chromosome translocation, known as the Philadelphia chromosome.
The resulting BCR/ABL1 fusion transcripts are present in approximately 95% of CML and 25–30% of acute lymphoblastic leukemia cases, according to the companies. The expression level of the fusion transcript or its ratio to a reference transcript may be used to monitor disease progress, they add. They believe that tracking the level of BCR/ABL1 may be helpful for both prognosis and management of Gleevec®, Sutent®, and Sprycell ® kinase therapies in patients with leukemia disease.
“Our development of a BCR/ABL1 test leverages both our expertise in molecular diagnostics development and our proprietary Armored RNA® technology,” asserts Rollie Carlson, Ph.D., president of Asuragen. “With streamlined multiplex workflow and inclusion of Armored RNA controls in the kit, the assay will have both broad target coverage and dynamic range while offering unmatched standardization for both internal and external assay calibration.”