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Alternative Name
ALK Mutation
Test Description

Bi-directional Sanger sequencing of ALK is performed using PCR primers designed to target hotspot mutations in exons 23 and 25.

Clinical Significance

ALK gene translocations are a well-known cause of gene deregulation and target of ALK inhibitors in non-small cell lung carcinoma (NSCLC). However, point mutations in the ALK tyrosine kinase domain, such as those detected by this test, are reported in patients who develop resistance to this therapy. Mutation analysis can help predict sensitivity or resistance to first and second generation inhibitors such as crizotinib, alectinib, and ceritinib. Reported mutations include L1152R, F1174V, F1245C, L1196M, and G1202R.

Note: This test is not designed to detect ALK fusions. To test for ALK rearrangement/fusions, either ALK for NSCLC FISH or Lung NGS Fusion Panel (Complete) are suggested.

Specimen Requirements
  • FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. All slides can be packed at room temperature.

CPT Code(s)*
New York Approved
Level of Service
Turnaround Time

7-10 days

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.