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Asuragen, Life Technologies Ink MDx Alliance

NEW YORK (GenomeWeb News) – Asuragen and Life Technologies have entered into an exclusive agreement to develop and commercialize a molecular diagnostic test to aid physicians in monitoring and treating patients with chronic myeloid leukemia.

Asuragen's BCR/ABL1 assay will simultaneously detect and quantify BCR/ABL1 fusion transcripts (b2a2, b3a2, and e1a2) in a single reaction, Austin, Texas-based Asuragen said. The BCR/ABL1 fusion transcripts are present in roughly 95 percent of CML and 25 percent to 30 percent of patients with acute lymphoblastic leukemia, the firm added.

Monitoring the level of these transcripts may prove helpful in prognosing and managing treatment with the drugs imatinib (Gleevec), sunitinib (Sutent), and dasatinib (Sprycell), Asuragen said.

Under terms of the agreement, Asuragen will pursue CE marked-IVD registration in Europe and regulatory clearance in the US. The test will be distributed by Life Technologies and run exclusively on Applied Biosystems/ 7500 Fast Dx Real-Time PCR Instrument. Financial and further terms were not disclosed.

Asuragen President Rollie Carlson said in a statement that he believes Life Technologies' "strong molecular instrumentation offerings and broad commercialization capabilities will lead to adoption of this test throughout the world."

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