Abbott inks companion Dx deal for J&J's 'breakthrough' cancer drug

Abbott Laboratories will develop a companion diagnostic for Johnson & Johnson's ibrutinib using its FISH technology.--Courtesy of Abbott Laboratories

Johnson & Johnson ($JNJ) scored a major victory with the FDA this month when the agency put its breakthrough designation on an investigational cancer drug, and now Abbott Laboratories ($ABT) is stepping in to develop a companion diagnostic for the headline-grabbing compound.

The drug, ibrutinib, is a small molecule inhibitor of the Bruton tyrosine kinase enzyme, designed to kill B-cell malignancies like leukemia and lymphoma. Abbott's role is to develop a test that can identify ideal patients with a genetic subtype of chronic lymphocytic leukemia, using the company's fluorescence in situ hybridization technology, or FISH.

Abbott's FISH-based test will target patients with a chromosome abnormality that makes them poor responders to chemoimmunotherapy but perfect for ibrutinib, the company said, potentially improving outcomes and speeding up treatment.

"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," Molecular Diagnostics Vice President John Coulter said in a statement. "Cancer is a complex disease where, historically, therapies have demonstrated only a 25% efficacy rate."

J&J is developing the drug with Pharmacyclics ($PCYC), and the FDA's plan to fast-track ibrutinib only adds to the excitement over the late-stage blockbuster hopeful. Now, if Abbott is successful and can come up with an assay that makes the treatment more effective by whittling down the patient population, J&J could have an even easier time making its case to regulators later this year.

As for the post-AbbVie ($ABBV) Abbott, diagnostics is an area the company is eyeing for growth now that it's without innovative drug revenue. Last quarter, the company posted 3.8% growth in core lab diagnostics and a 14.7% jump for its up-and-coming point-of-care business, and Abbott is looking to expand its presence in companion diagnostics, with deals like this one and a similar agreement to identify non-small cell lung cancer patients for Pfizer's ($PFE) Xalkori.

- read Abbott's announcement