Gene Rearrangements Suggest Specific Form of NSCLC

A new molecular test identifies the presence of gene rearrangements associated with a specific form of non-small-cell lung cancer (NSCLC).

These rearrangements occur in a gene known as anaplastic lymphoma kinase (ALK). The Vysis ALK Break Apart FISH probe kit uses fluorescence in situ hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome in tumors. FISH technology 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.

Also known as the Abbott (Abbott Park, IL, USA) ALK test, the new assay will be used for testing, research, and to support evaluations of new therapies in multinational government funded studies. It is commercially available in the United States and CE-Mark countries only. Registration of the new test is under way in Australia, China, Korea, Malaysia, Singapore, and Taiwan.

Lung cancer is the world’s leading cause of cancer death with more than 1.6 million new cases diagnosed each year. About 85% of lung cancer patients have the non-small-cell type, and usually they are diagnosed with advanced disease with a very low survival rate. About 3% to 5% of these patients are thought to have ALK gene rearrangements and have been shown to respond to therapies that block the ALK pathway.

"A better understanding of the underlying molecular mechanisms of lung cancer may lead to improvements in the treatment of the disease," said Stafford O’Kelly, head of Abbott’s Molecular Diagnostics (Wiesbaden, Germany). "Developing new tests that identify genetic biomarkers in non-small-cell lung cancer and other types of disease is critical to advancing patient care around the world and remains an important scientific focus for Abbott."

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