Anaplastic Lymphoma Kinase for Lung Cancer, Immunohistochemistry
Use
The test is useful for the identification of anaplastic lymphoma kinase (ALK) expression and for predicting tumor response to targeted therapy in non-small cell lung carcinomas, specifically adenocarcinomas that harbor ALK rearrangements. ALK expression in tumor cells is a surrogate marker for ALK rearrangement, which is a predictive biomarker for response to ALK tyrosine kinase inhibitors.
Special Instructions
A pathology/diagnostic report and brief history of the primary site of neoplasm are required. For initial immunohistochemistry (IHC) stain, the appropriate bill-only test ID will be added and charged (IHPCI). For each additional IHC stain, an additional bill-only test ID will be added and charged (IHPCA).
Limitations
This test has been validated for non-decalcified paraffin-embedded tissue specimens fixed in 10% neutral buffered formalin. Specimens should be placed in formalin within 1 hour of acquisition and fixed for 6 to 48 hours. Not validated on tissue or cellblocks subjected to alternative fixatives or decalcification. Antigen stability varies, with a recommendation for paraffin sections to be cut within 6 weeks. The charge of glass slides can affect slide staining, impacting consistency.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 47303-3
- 59465-5
- 19139-5
- 81178-6
- 62364-5
- 80398-1
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Formalin-fixed, paraffin-embedded tissue block or 3 unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue
Causes for Rejection
Wet/frozen tissue, decalcified paraffin embedded tissue, cytology smears, nonformalin fixed tissue including alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER fixatives or zinc formalin, nonparaffin embedded tissue, noncharged slides, ProbeOn slides, Snowcoat slides