Abbott,a global, broad-based health care company, plans to expand the current CE-IVD product labelling for its Vysis ALK Break Apart FISH Probe Kit, allowing the test to be marketed in the European Union as a companion diagnostic. The test is designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in advanced non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with XALKORI (crizotinib), an oral first-in-class ALK inhibitor.

The Vysis ALK test kit uses Abbott's proprietary fluorescence in situ hybridization (FISH) technology and was the only diagnostic test used in multi-center global clinical trials in conjunction with Pfizer’s XALKORI (crizotinib). Patients in these global clinical trials for XALKORI were screened with Abbott’s ALK FISH test to detect possible gene rearrangements and allow physicians to make important treatment decisions.

The Abbott test has been used by oncologists in the United States since it was co-approved with XALKORI by the US Food and Drug Administration (FDA) in August 2011. The test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from the new therapy. In Europe, the CE-IVD test has been available to laboratories since September 2011 and has been used primarily in academic studies and to support evaluations of new therapies.

"Laboratories throughout Europe are familiar with and experienced in using the Vysis ALK FISH test so they will be able to start testing lung cancer patients immediately to help doctors decide if XALKORI is the right treatment option for them," said Kristina Rodnikova, head of Abbott’s molecular diagnostics business in Europe.

Similar to the Abbott ALK test’s ability to identify patients for XALKORI therapy, Abbott's CE Marked PathVysion test, detects amplification of the HER-2 gene and acts as an aid in identifying patients for Herceptin (trastuzumab) therapy for breast and stomach cancer. In nearly 15 years of clinical experience, the FISH HER-2 assay has tested thousands of patients and allowed them to begin life-saving therapy with Herceptin. PathVysion was also the first FDA approved FISH-based companion diagnostic test.

A year of clinical laboratory experience since its approval in the United States has established the value of the Vysis ALK Break Apart FISH assay as a rapid, sensitive and specific test for detecting ALK gene rearrangements in patients with NSCLC. To date, no other tests for detecting patients with ALK-positive lung cancer have been validated in clinical trials performed to establish clinical benefit from XALKORI in the treatment of ALK-positive NSCLC.

FISH (fluorescence in-situ hybridization) 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 tumors, 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.