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Abbott Submits Applications for PGx Cancer Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Abbott today said that it has completed submissions in the US and Japan for a molecular diagnostic test to detect abnormal gene rearrangements in non-small cell lung cancer tumors.

The test uses fluorescence in situ hybridization technology and has been developed to detect rearrangements in the 2p23 chromosome of the ALK gene. Abbott said that these abnormalities have been implicated in the development of NSCLC, lymphoma, and neuroblastoma.

"The Abbott ALK FISH test is designed to help physicians select appropriate patients with non-small-cell lung cancer for targeted drug treatment," Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement.

The test is currently being used in clinical trials with Pfizer's crizotinib, an anaplastic lymphoma kinase inhibitor. Last week, Pfizer filed for US and Japanese approval of the drug. The US Food and Drug Administration has given the drug, which some analysts believe could eventually bring in annual sales of $2.5 billion, priority review status.

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