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Abbott files for new lung cancer test approval in US, Japan

Abbott has filed premarket approval applications to the US Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour, and Welfare for a new molecular diagnostic test.

The test, a combination product to be used with Pfizer’s oral first-in class anaplastic lymphoma kinase (ALK) inhibitor – crizotinib, is designed to detect abnormal gene rearrangements in non-small-cell lung cancer (NSCLC) tumors.

The new Abbott test uses fluorescence in situ hybridization technology (FISH) and is designed to detect rearrangements of the 2p23 chromosome of the ALK gene.

The proprietary FISH technology allows direct detection of chromosomal abnormalities and also permits the quantitative assessment of morphological changes in cells, enabling clinicians to investigate DNA in its native, chromosomal form within the cell nucleus.

Abbott Molecular Diagnostics Business head Stafford O’Kelly said the Abbott ALK FISH test is designed to help physicians select appropriate patients with non-small-cell lung cancer for targeted drug treatment.