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IASLC ATLAS OF ALK TESTING IN LUNG CANCER
ALK RT-PCR: the names of any clinically signi?cant mutations that have been identi?ed; the fusion pattern, such as “variant 1,” has been used, but it is recommended to use descriptions (Soda 2012) such as “EML4-ALK (E13;A20)” for variant 1 and “EML4-ALK (E14;A20 E14;ins11del49A20)” for variant 4. (Additional information is available at http://atlasgeneticsoncology.org/Tumors/ inv2p21p23NSCCLungID5667.html.)
Interpretation/Conclusion Section
This section should include the following. • Specimen type and diagnosis (primary or after treatment with an ALK inhibitor) • Easily understandable clinical interpretation, including outcome of the molecular test and an overall statement of the likelihood that the cancer will respond to or resist ALK inhibitor therapy (considering also the clinical evidence) • Explanation (as best as is known) for an inconclusive result or discrepant results with multiple testing, whether due to assay failure, insufficient specimen, or another reason (e.g., atypical FISH patterns) and suggestion of requirements for testing a different specimen that would be more likely to yield a successful result
Conclusion
Reports on the results of ALK testing should include sufficient details for both laboratory physicians and clinicians to understand the origin and features of the sample tested, the nature of the test performed, and the accuracy and potential clinical utility of the results.