ALK FISH, Non-Small-cell Lung Cancer

Confirmation/identification of non-small-cell lung cancer (this is a test for the identification of NSCLC patients who may be eligible for treatment); qualitative/quantitative evaluation of ALK rearrangement

This test is used for confirmation/identification of non-small-cell lung cancer (this is a test for the identification of NSCLC patients who may be eligible for treatment) and qualitative/quantitative evaluation of ALK rearrangement.

Use of fixatives other than 10% formalin or fixation times less than six hours or more than 72 hours may not yield reliable results. Suboptimal pre-analytic variables, including cold ischemia time outside the recommended guidelines, extended duration of fixation, fixation other than paraformaldehyde, and tissue decalcification, may negatively impact results. Results of the ALK FISH assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, and other known risk factors.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Molecular mutations or chromosomal alterations not targeted by the probe included in this profile will not be detected. 

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.