Includes all controls.


ALK Resistance Mutations and Cancer

Chromosomal translocations involving the anaplastic lymphoma kinase (ALK) gene have been found in various cancers, including 3-7% of non-small cell lung cancer (NSCLC). These in-frame rearrangements fuse the kinase domain of ALK with other genes, producing a chimeric protein with oncogenic potential. Recently developed kinase inhibitors that target the kinase domain of ALK are currently used to treat ALK fusion positive NSCLC patients.


Assay Features

The EML4-ALK Fusion Gene Detection Kit provides reagents for detection of 9 EML4-ALK fusion gene variants that have been found in lung tumors. The assay combines first-strand cDNA synthesis (reverse transcription) and simultaneous amplification of mutant ALK and reference genes in a single step. The kit detects 7 variants (1, 2, 3a/b, 5a/b & 6) in one reaction, but does not distinguish between them, and 2 variants (4 & 7) in a second reaction, but does not distinguish between them.

This kit is compatible with various sample types and can be used to detect mutations in RNA isolated from cell lines, fresh-frozen tissues, formalin-fixed paraffin-embedded (FFPE) tissues.


The EML4-ALK Fusion Gene Detection Kit detects the following ALK mutations:

  • variant 1 (E13;A20)
  • variant 2 (E20;A20)
  • variant 3a (E6;A20)
  • variant 3b (E6;insA20)
  • variant 4 (E14;(-49)A20)
  • variant 5a (E2;A20)
  • variant 5b (E2;(+117)A20)
  • variant 6 (E13;(+69)A20)
  • variant 7 (E14;(-13)A20)

Equipment and Materials

The EML4-ALK Fusion Gene Detection Kit requires a real-time PCR instrument capable of detecting FAM and VIC fluorescent probes. This kit includes primer/probe mix for detection of all 9 variants, one-step enzyme mix for cDNA synthesis and PCR, as well as validated control standards. Columns and reagents for RNA isolation are not included.

This test includes reagents required for the PCR amplification/detection, as well as validated reaction controls. Columns and reagents for DNA isolation are not included.


Intended Use

USA: Available for research use only (RUO). Not for use in diagnostic procedures.

Europe: Available for research (RUO) and diagnostic (CE-IVD) purposes.

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