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Asuragen Signs Deal with Novartis to Develop Standardization Tools for BCR-ABL Monitoring

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Asuragen has entered into an exclusive agreement with Novartis for the worldwide development of Armored RNA Quant BCR-ABL1 RNA International Scale calibrators and laboratory software reporting tools. The products are aimed at helping laboratories standardize BCR-ABL testing when treating Philadelphia chromosome-positive chronic myelogenous leukemia patients with the Novartis oncologic Gleevec.

The BCR-ABL1 RNA IS calibrators "are intended to be compatible with several widely used assays, including both commercially available and laboratory developed tests," Asuragen said in a statement. Meanwhile, the software reporting tool is "expected to help standardize how BCR-ABL1 RT-qPCR results are reported according to the International Scale," the company added.

The International Scale was first proposed by leukemia researchers at a 2005 meeting to serve as a global standard for detecting and reporting BCR-ABL transcript levels. A paper outlining the standard was published the following year in Blood.

As Asuragen is developing these standardization tools, Novartis is also working with Cepheid to advance a BCR-ABL gene transcript monitoring test, which it hopes will help doctors more reliably manage Philadelphia chromosome-positive chronic myelogenous leukemia patients treated with Gleevec (PGx Reporter 10/13/10).

Gleevec has been on the market for a decade for the treatment of Ph+ CML, and among oncologists it is already standard practice to molecularly monitor BCR-ABL transcript levels to confirm patients have the disease and to ensure patients aren't relapsing or having a refractory response to treatment. However, there is a lack of standardized procedures and reference materials in leukemia monitoring, which can make it difficult to compare results obtained from different labs.

This deal with Asuragen is part of Novartis' ongoing effort to facilitate lab standardization while conducting BCR-ABL testing. Under the terms of its agreement with Novartis, Asuragen will develop and distribute the calibrators and software reporting tools to laboratories globally either directly or through distributors.

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