Abbott to develop companion diagnostic test for investigational leukemia therapy

Under the agreement, Abbott will leverage its proprietary Vysis CLL fluorescence in situ hybridization (FISH) Probe kit to develop a test for identifying high-risk chronic lymphocytic leukemia (CLL) patients who have a deletion within a specific chromosome (chromosome 17p (del17p)) and may respond to ibrutinib.

The kit targets multiple genes including tumor protein p53 gene (TP53), located on chromosome 17p, within the del17p region, to determine prognosis for patients with CLL, according to Abbott.

Abbott molecular diagnostics vice president John Coulter said 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," Coulter added.

Ibrutinib, an oral small molecule inhibitor of Bruton tyrosine kinase (BTK), is currently in development by Janssen and Pharmacyclics for several B-cell malignancies including chronic leukemia and lymphoma.