Abbott announced the availability of a new molecular test in the European Union and New Zealand designed to identify the presence of gene rearrangements associated with a specific form of Non-Small-Cell Lung Cancer (NSCLC). These rearrangements in a gene known as ALK (Anaplastic Lymphoma Kinase) have been implicated in the formation of cancerous tumours in patients with NSCLC.

Lung cancer is the world’s leading cause of cancer death with more than 1.6 million new cases diagnosed each year. About 85 per cent of lung cancer patients have the non-small-cell type and are usually diagnosed with advanced disease with a very low survival rate. About 3-5 per cent of those patients are thought to have ALK gene rearrangements and have been shown to respond to therapies that block the ALK pathway. The Vysis ALK Break Apart FISH probe kit, commonly known as the Abbott ALK test, uses Abbott’s Fluorescence In Situ Hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome in tumours. The new Abbott assay will be used for research, testing, and to support evaluations of new therapies in multi-national government funded studies.

“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 business. “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.”

Abbott’s ALK FISH test was approved in the United States on Aug. 26, 2011. It is commercially available in the US and CE-Mark countries only. Registration of the new test is under way in Australia, China, Korea, Malaysia, Singapore, and Taiwan.

FISH technology has a variety of uses. It 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. Since the technology works especially well for identifying genetic markers in solid tumours, cancer diagnostics are one of the fastest growing applications.

Abbott Molecular is a leader in molecular diagnostics — the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential for earlier detection or diagnosis, can influence the selection of appropriate therapies, and may improve monitoring of disease progression.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.