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Cepheid, Novartis Partner to Bring Leukemia Test to US

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Cepheid today announced a partnership with Novartis to commercialize a molecular diagnostic test for Philadelphia chromosome-positive chronic myelogenous leukemia, or Ph+CML.

The Xpert BCR-ABL test is based on Cepheid's GeneXpert system. It is CE marked and has been available for sale outside the US since 2006. The deal announced today would accelerate efforts to get clearance from the US Food and Drug Administration for commercial launch in the US of the test.

Under the terms of the deal, Novartis will fund clinical studies and other development costs, Cepheid said in a statement. Additionally, Cepheid will receive an upfront payment of $5 million and milestone payments of $3 million over the next 12 months.

Upon commercial release of the Xpert BCR-ABL test in the US, Novartis would have exclusive rights to distribute the test worldwide under a Cepheid/Novartis label. Other diagnostic development efforts will also be explored by the two firms after US commercial release, said Cepheid.

The test is for monitoring the BCR-ABL gene transcript in peripheral blood samples from patients diagnosed with Ph+CML. Used in conjunction with other lab tests, it will help in managing the disease, Cepheid said.

In a statement, the Sunnyvale, Calif.-based company said that Ph+CML patients have access to a broad range of tyrosine kinase inhibitors, and a standardized molecular monitoring BCR-ABL test is expected "to support optimal patient management decisions."

In developing the test, which would be linked to an internationally accepted standard called the "International Scale," the firms hope to remove variability that is currently inherent in BCR-ABL testing, Cepheid said.

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