Abbott Develop Companion Test for Investigational Leukemia Therapy

Abbott announced today that it will collaborate with Janssen Biotech, Inc. and Pharmacyclics, Inc. to explore the benefits of Abbott's proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.

Under the agreement, Abbott will develop a FISH-based test to identify high-risk CLL patients who have a deletion within a specific chromosome (chromosome 17p (del17p)) and may respond to ibrutinib, an oral, small molecule inhibitor of Bruton tyrosine kinase (BTK). Ibrutinib is currently in development by Janssen and Pharmacyclics for several B-cell malignancies, including chronic leukemia and lymphoma. Patients harboring a deletion within chromosome 17p are poor responders to chemoimmunotherapy and have limited treatment options. Having a test that is able to accurately detect the 17p deletion identifies a specific patient population with a high unmet medical need.

"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 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."

According to the American Society of Clinical Oncology (ASCO), future cancer therapies will be developed through molecular approaches that can accelerate development of more effective, personalized treatments. Identifying specific genetic characteristics of malignancies is expected to also support development of new treatments that target specific proteins involved in the development and growth of cancer.

In 2011, Abbott received U.S. Food and Drug Administration clearance for its Vysis CLL FISH Probe Kit. The kit targets multiple genes, including TP53 (tumor protein p53 gene, located on chromosome 17p) within the del17p region, 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.

FISH (fluorescence in-situ hybridization) technology has a variety of uses. It can identify whether too many, or too few, copies of a particular gene are present in the body's cells or whether certain genes have rearrangements that play an active role in disease progression. Since the technology works especially well for identifying genetic markers in solid tumors, cancer diagnostics are one of the fastest growing applications.