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Janssen Biotech, Pharmacyclics Explore Abbott FISH Technology as CDx for CLL

NEW YORK (GenomeWeb News) – Abbott today announced a collaboration to explore the use of its fluorescence in situ hybridization technology as a companion diagnostic for an investigational drug being developed by Johnson & Johnson's Janssen Biotech and Pharmacyclics for treating chronic lymphocytic leukemia.

Abbott will develop a FISH-based test for identifying high-risk CLL patients with a deletion within chromosome 17p and who may respond to ibrutinib, a small molecule inhibitor of Bruton tyrosine kinase. Janssen and Pharmacyclics are developing ibrutinib for several B-cell malignancies including CLL.

Patients with a deletion within chromosome 17p respond poorly to chemoimmunotherapy and have limited therapeutic options. Being able to detect the deletion would identify a patient population with a high unmet medical need, Abbott said.

Abbott's Vysis CLL FISH Probe Kit will be used for investigational use only as part of today's deal in order to determine genetic marker status, Abbott said. The kit, which was cleared by the US Food and Drug Administration in 2011, targets multiple genes, such as TP53 within the deleted 17p region, and is used to determine the prognosis of CLL patients.

"[O]our goal is to leverage molecular technologies to help ensure that the right medicine is getting to the right person," John Coulter, vice president of Molecular Diagnostics for Abbott, said in a statement. "Cancer is a complex disease where, historically, therapies have demonstrated only a 25 percent efficacy rate. Companion diagnostic tests can help improve these outcomes by selecting patients that are more likely to respond to specific therapies, reducing time to the most effective treatment and increasing the number of positive outcomes."

Financial and other terms of the deal were not disclosed.

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