Asuragen inked an exclusive agreement with Novartis to develop international scale (IS) calibrators and laboratory software reporting tools for Bcr-Abl1 test results generated from RT qPCR. The IS calibrators are intended to be compatible with several widely used assays including commercially available and laboratory developed tests.
The deal follows Novartis' collaboration with molecular diagnostics company Cepheid, inked in October, to develop a new Bcr-Abl test that adheres to the international scale. The goal is to help doctors more reliably monitor Philadelphia chromosome positive chronic myeloid leukemia patients.
Cepheid and Novartis also will develop a tool to enable more sensitive testing, indicating the depth of a patient’s response to tyrosine kinase inhibitors including its products Tasigna and Glivec. Currently there are no FDA cleared/approved tests to monitor for Bcr-Abl.
Asuragen will develop the tools on its Armored RNA® technology. It will also be responsible for global distribution of Armored RNA Quant (ARQ) BCR-ABL1 RNA IS calibrators and reporting solutions.
The Armored RNA platform controls potential failures of sample preparation and assay performance in viral RNA testing, says Asurage. The coat protein of E. coli bacteriophage MS2 was used to package RNA fragments encoding target-specific viral sequences such as HIV and HCV. As a result, the packaged RNA is stable and ribonuclease-resistant in plasma and other matrices, the firm points out.