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Abbott, Janssen, Pharmacyclics in Diagnostics Pact

To develop FISH-based test to identify high-risk CLL patients

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Abbott will collaborate with Janssen Biotech and Pharmacyclics to explore Abbott’s FISH (Fluorescence In Situ Hybridization) technology for the development of a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.
 
Abbott will develop a FISH-based test to identify high-risk CLL patients that may respond to ibrutinib, an oral, small molecule inhibitor currently in development by Janssen and Pharmacyclics for several B-cell malignancies, including CLL.
 
“Like Abbott’s other collaborations in the area of companion diagnostics, our goal is to leverage molecular technologies to help ensure that the right medicine is getting to the right person,” said John Coulter, vice president, Molecular Diagnostics, Abbott.  “Cancer is a complex disease where, historically, therapies have demonstrated only a 25% 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.”
 
In 2011, Abbott received FDA clearance for its Vysis CLL FISH Probe Kit. The kit targets multiple genes and is used as an aid for determining prognosis for patients with CLL. Abbott’s Vysis CLL FISH Probe Kit will be used for investigational use only to determine genetic marker status as part of the co-development efforts between Janssen, Pharmacyclics and Abbott.

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