Abbott completes submission of new molecular test

Abbott today announced it filed premarket approval applications to the U.S. Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare for a new molecular diagnostic test designed to detect abnormal gene rearrangements in non-small-cell lung cancer (NSCLC) tumors. The test is a combination product to be used with Pfizer’s crizotinib, an oral first-in class anaplastic lymphoma kinase (ALK) inhibitor.

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. These genetic abnormalities have been implicated in the development of NSCLC, lymphoma and neuroblastoma.

“As more is learned about cancer and tumor formation, genetic biomarker identification will become an increasingly valuable protocol governing the use of new personalized medications,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business. “The Abbott ALK FISH test is designed to help physicians select appropriate patients with non-small-cell lung cancer for targeted drug treatment. It is the only test being used in multi-center global clinical trials in conjunction with Pfizer’s crizotinib.”

Lung cancer is the world’s leading cancer cause of death with more than 1.6 million new cases diagnosed each year. About 85 percent of lung cancer patients have the non-small-cell type and are usually diagnosed with advanced disease with a very low survival rate. Patients diagnosed with NSCLC who also testpositive for the ALK gene rearrangement are the most appropriate candidates for treatment with an ALK inhibitor therapy.

About FISH

Abbott Molecular develops and markets FISH probes, offering a broad menu of tests for use in cancer diagnostics and genetic testing. The proprietary technology allows highly sensitive, 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 manufactures some 728 individual FISH probes, which find use not only in diagnosis and prognosis, but also to predict therapeutic response and aid in the surveillance and monitoring of disease.