Feb 21 Abbott Laboratories said on
Thursday it was working with Johnson & Johnson to see if
a genetic diagnostic test made by Abbott would help to identify
patients most likely to benefit from a promising experimental
The drug, ibrutinib, which is being developed by J&J and
Pharmacyclics Inc for chronic lymphocytic leukemia
(CLL), recently became one of the first five drugs to receive
the new "breakthrough" designation from the U.S. Food and Drug
The designation is being awarded to experimental drugs the
agency views as potentially substantial improvements over
existing therapies in a coordinated effort to get the medicines
to patients faster. Twelve more drugs are currently under
consideration for breakthrough status, the FDA said.
Under the collaboration, Abbott will develop a companion
diagnostic test to identify high-risk CLL patients who have an
abnormality within a specific chromosome that makes them most
likely to respond to treatment with ibrutinib.
The Abbott technology known as FISH - fluorescence in-situ
hybridization - 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.
With advances in genetic screening and better understanding
of the molecular biology of cancer, many more drugs are expected
to be developed along with companion diagnostics.
Abbott previously worked with Pfizer Inc to develop
a companion diagnostic for Pfizer's Xalkori to identify the
estimated 4 percent of lung cancer patients with a specific gene
mutation called ALK that the drug targets. That drug and the ALK
test were approved in 2011.