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Asuragen to Develop BCR-ABL1 RT-qPCR Testing Calibrators, Software for Novartis


Asuragen said this week that it has entered into an exclusive agreement with Novartis to develop software to aid laboratories with standardization of BCR-ABL1 RT-qPCR testing to the International Scale.

Under the deal, Asuragen will develop Armored RNA Quant BCR-ABL1 RNA International Scale calibrators and laboratory software reporting tools to help laboratories standardize testing when treating Philadelphia chromosome-positive chronic myelogenous leukemia patients with Novartis' Gleevec.

Asuragen will then distribute the calibrators and software to laboratories globally either directly or through distributors, the company said.

Financial terms of the agreement were not disclosed.

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," Asuragen said.

The International Scale is an internationally vetted and accepted standard for monitoring BCR-ABL transcript levels in Ph+ CML patients, and results linked to the scale are important to determine whether a patient has achieved certain therapy milestones.

Under an agreement announced in October, Novartis is working with Cepheid to develop and commercialize a BCR-ABL gene transcript test to monitor BCR-ABL gene transcripts in peripheral blood from patients with Ph+ CML to help manage Philadelphia chromosome-positive chronic myelogenous leukemia patients treated with Gleevec.

Novartis noted at the time that it planned to link results from the test to the International Scale (PCR Insider, 10/14/2010).