Trial Information

Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)

The ALK Break Apart FISH test detects chromosomal aberrations via fluorescence in situ
hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer
(NSCLC) tissue specimens. The FDA approved ALK kit is designed to detect rearrangements
involving the ALK gene (2p23). Results from the ALK Kit are intended for use, in conjunction
with and not in lieu of current standard diagnostic procedures, as an aid for the
pathologist in the identification of patients eligible for treatment with XALKORI®
(crizotinib).