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Abbott
announced
today that it will expand the current CE-IVD product labeling 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 U.S. Food and Drug Administration 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.
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